Adverse Event Listing

Listing of Treatment-Emergent Adverse Events

Setup

See Prerequisites for installation instructions.

library(arframe)
library(pharmaverseadam)
library(dplyr, warn.conflicts = FALSE)

arm_levels <- c("Placebo", "Xanomeline Low Dose", "Xanomeline High Dose")

ae_listing <- pharmaverseadam::adae |>
  blank_to_na() |>
  filter(
    TRTEMFL == "Y",
    TRT01A %in% arm_levels
  ) |>
  mutate(
    TRT01A  = factor(TRT01A, levels = arm_levels),
    AESEV   = factor(AESEV, levels = c("MILD", "MODERATE", "SEVERE")),
    ASTDT   = format(ASTDT, "%d %b %Y"),
    AENDT   = format(AENDT, "%d %b %Y"),
    ASTDT   = if_else(is.na(ASTDT), "Ongoing", ASTDT),
    AENDT   = if_else(is.na(AENDT), "Ongoing", AENDT)
  ) |>
  arrange(TRT01A, USUBJID, AEBODSYS, AEDECOD) |>
  select(
    TRT01A,
    USUBJID,
    AEBODSYS,
    AEDECOD,
    AESEV,
    ASTDT,
    AENDT,
    AEOUT,
    AEREL
  )

arframe Pipeline

ae_listing |>
  fr_table() |>
  fr_titles(
    "Listing 16.2.7.1",
    "Listing of Treatment-Emergent Adverse Events",
    "Safety Population"
  ) |>
  fr_cols(
    TRT01A   = fr_col(visible = FALSE),
    USUBJID  = fr_col("Subject ID",    width = 1.2),
    AEBODSYS = fr_col("System Organ\nClass", width = 2.2),
    AEDECOD  = fr_col("Preferred\nTerm",     width = 2.0),
    AESEV    = fr_col("Severity",      width = 0.9, align = "center"),
    ASTDT    = fr_col("Start\nDate",   width = 1.1, align = "center"),
    AENDT    = fr_col("End\nDate",     width = 1.1, align = "center"),
    AEOUT    = fr_col("Outcome",       width = 1.3),
    AEREL    = fr_col("Relationship\nto Study Drug", width = 1.3)
  ) |>
  fr_header(bold = TRUE, align = "center") |>
  fr_rows(page_by = "TRT01A", sort_by = c("USUBJID", "AEBODSYS", "AEDECOD"), suppress = "USUBJID") |>
  fr_footnotes(
    "TEAE = Treatment-Emergent Adverse Event: onset on or after first dose date.",
    "Outcome: RECOVERED/RESOLVED, RECOVERING/RESOLVING, NOT RECOVERED/NOT RESOLVED, FATAL, UNKNOWN.",
    "Relationship: RELATED, NOT RELATED, POSSIBLY RELATED.",
    "Sorted by treatment arm, subject, system organ class, and preferred term."
  )

Rendered Listing

This is a subject-level listing – no summarisation. fr_table() is called directly on the data. Pages are broken by treatment arm using page_by.

Listing 16.2.7.1

Listing of Treatment-Emergent Adverse Events

Safety Population

Placebo

Subject ID	System Organ Class	Preferred Term	Severity	Start Date	End Date	Outcome	Relationship to Study Drug
01-701-1015	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	09 Jan 2014	11 Jan 2014	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	03 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	03 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1023	CARDIAC DISORDERS	ATRIOVENTRICULAR BLOCK SECOND DEGREE	MILD	26 Aug 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	07 Aug 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	07 Aug 2012	30 Aug 2012	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	07 Aug 2012	30 Aug 2012	RECOVERED/RESOLVED	POSSIBLE
01-701-1047	CARDIAC DISORDERS	BUNDLE BRANCH BLOCK LEFT	MILD	10 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	HIATUS HERNIA	MODERATE	12 Feb 2013	12 Feb 2013	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	HIATUS HERNIA	MODERATE	12 Feb 2013	12 Feb 2013	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	06 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-701-1130	EYE DISORDERS	EYE ALLERGY	MILD	09 May 2014	09 May 2014	RECOVERED/RESOLVED	NONE
	EYE DISORDERS	EYE PRURITUS	MILD	22 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	EYE DISORDERS	EYE SWELLING	MILD	09 May 2014	09 May 2014	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PYREXIA	MILD	09 Mar 2014	09 Mar 2014	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	URINARY TRACT INFECTION	MILD	09 Mar 2014	16 Mar 2014	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	URINARY TRACT INFECTION	MILD	09 Mar 2014	16 Mar 2014	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	22 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	22 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-701-1153	METABOLISM AND NUTRITION DISORDERS	INCREASED APPETITE	MILD	13 Oct 2013	06 Nov 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	METABOLISM AND NUTRITION DISORDERS	INCREASED APPETITE	MILD	13 Oct 2013	06 Nov 2013	RECOVERED/RESOLVED	POSSIBLE
01-701-1203	SURGICAL AND MEDICAL PROCEDURES	EYE LASER SURGERY	MILD	21 Mar 2013	21 Mar 2013	RECOVERED/RESOLVED	NONE
01-701-1363	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	14 Jun 2013	15 Jun 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	16 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MILD	13 Oct 2013	15 Oct 2013	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MILD	13 Oct 2013	15 Oct 2013	RECOVERED/RESOLVED	NONE
01-701-1387	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	18 Mar 2014	18 Mar 2014	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	18 Mar 2014	18 Mar 2014	RECOVERED/RESOLVED	REMOTE
01-701-1392	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	16 Mar 2013	21 Mar 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	16 Mar 2013	21 Mar 2013	RECOVERED/RESOLVED	REMOTE
01-701-1415	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	09 Mar 2014	09 Mar 2014	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	21 Oct 2013	04 Nov 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	21 Oct 2013	04 Nov 2013	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	21 Jan 2014	10 Feb 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	21 Jan 2014	10 Feb 2014	RECOVERED/RESOLVED	REMOTE
	RENAL AND URINARY DISORDERS	MICTURITION URGENCY	MILD	02 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-703-1042	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	04 Mar 2013	05 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	INSOMNIA	MILD	05 Mar 2013	06 Mar 2013	RECOVERED/RESOLVED	REMOTE
01-703-1100	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	05 Apr 2013	16 Apr 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	05 Apr 2013	16 Apr 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	05 Apr 2013	16 Apr 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MILD	17 Jul 2013	14 Sep 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MILD	17 Jul 2013	14 Sep 2013	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MODERATE	27 May 2013	03 Jun 2013	RECOVERED/RESOLVED	REMOTE
	SURGICAL AND MEDICAL PROCEDURES	CATARACT OPERATION	MODERATE	25 Apr 2013	25 Apr 2013	RECOVERED/RESOLVED	NONE
01-703-1210	METABOLISM AND NUTRITION DISORDERS	DECREASED APPETITE	MODERATE	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	METABOLISM AND NUTRITION DISORDERS	DECREASED APPETITE	MILD	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	DISORIENTATION	MILD	02 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-703-1299	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MODERATE	13 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	TACHYCARDIA	MODERATE	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	TACHYCARDIA	MILD	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	27 Sep 2012	06 Oct 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	27 Sep 2012	06 Oct 2012	RECOVERED/RESOLVED	NONE
	VASCULAR DISORDERS	HYPOTENSION	MODERATE	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	VASCULAR DISORDERS	HYPOTENSION	MILD	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-704-1010	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	05 Jul 2014	06 Jul 2014	RECOVERED/RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	05 Jul 2014	06 Jul 2014	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	CYSTITIS	MILD	27 Feb 2014	06 Mar 2014	RECOVERED/RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	06 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MILD	06 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	SKIN LACERATION	MILD	06 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MILD	06 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-704-1164	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MILD	04 Feb 2013	13 Feb 2013	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	INFLUENZA	MILD	27 Sep 2012	07 Oct 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	INFLUENZA	MILD	27 Sep 2012	07 Oct 2012	RECOVERED/RESOLVED	NONE
01-704-1351	GASTROINTESTINAL DISORDERS	FLATULENCE	MILD	27 Oct 2013	04 Apr 2014	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	FLATULENCE	MILD	27 Oct 2013	04 Apr 2014	RECOVERED/RESOLVED	NONE
	RENAL AND URINARY DISORDERS	POLLAKIURIA	MILD	27 Oct 2013	04 Apr 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RENAL AND URINARY DISORDERS	POLLAKIURIA	MILD	27 Oct 2013	04 Apr 2014	RECOVERED/RESOLVED	NONE
01-704-1435	NERVOUS SYSTEM DISORDERS	PARKINSON'S DISEASE	MILD	06 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-704-1445	PSYCHIATRIC DISORDERS	COMPLETED SUICIDE	SEVERE	31 Oct 2014	31 Oct 2014	FATAL	NONE
01-705-1059	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	02 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-705-1186	HEPATOBILIARY DISORDERS	HYPERBILIRUBINAEMIA	MODERATE	26 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-705-1349	CARDIAC DISORDERS	VENTRICULAR HYPERTROPHY	MILD	25 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	08 Apr 2013	08 Apr 2013	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	11 Apr 2013	11 Apr 2013	RECOVERED/RESOLVED	REMOTE
	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	25 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-706-1041	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	07 Jan 2014	08 Jan 2014	RECOVERED/RESOLVED	REMOTE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MILD	14 Jan 2014	28 Jan 2014	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MILD	14 Jan 2014	28 Jan 2014	RECOVERED/RESOLVED	NONE
	PSYCHIATRIC DISORDERS	IRRITABILITY	MODERATE	15 Jan 2014	29 Jul 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	IRRITABILITY	MODERATE	15 Jan 2014	29 Jul 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Mar 2014	29 Jul 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Mar 2014	29 Jul 2014	RECOVERED/RESOLVED	POSSIBLE
01-707-1206	CARDIAC DISORDERS	SINUS ARRHYTHMIA	MILD	25 Nov 2013	23 Dec 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	SINUS ARRHYTHMIA	MILD	25 Nov 2013	23 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	EYE DISORDERS	CONJUNCTIVITIS	MODERATE	08 Feb 2014	22 Feb 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	EYE DISORDERS	CONJUNCTIVITIS	MODERATE	08 Feb 2014	22 Feb 2014	RECOVERED/RESOLVED	REMOTE
	INVESTIGATIONS	BLOOD CREATINE PHOSPHOKINASE INCREASED	MODERATE	26 Nov 2013	09 Dec 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INVESTIGATIONS	BLOOD CREATINE PHOSPHOKINASE INCREASED	MODERATE	26 Nov 2013	09 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	POSTNASAL DRIP	MILD	03 Dec 2013	10 Dec 2013	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	POSTNASAL DRIP	MILD	03 Dec 2013	10 Dec 2013	RECOVERED/RESOLVED	NONE
01-708-1087	INVESTIGATIONS	HEART RATE IRREGULAR	MILD	19 Jan 2013	19 Jan 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INVESTIGATIONS	HEART RATE IRREGULAR	MILD	19 Jan 2013	19 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	INVESTIGATIONS	HEART RATE IRREGULAR	MILD	16 Mar 2013	16 Mar 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INVESTIGATIONS	HEART RATE IRREGULAR	MILD	16 Mar 2013	16 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	04 Feb 2013	08 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	16 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-708-1158	PSYCHIATRIC DISORDERS	AGITATION	MILD	25 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	22 Mar 2014	22 Mar 2014	RECOVERED/RESOLVED	PROBABLE
01-708-1253	INVESTIGATIONS	HEART RATE INCREASED	MILD	07 May 2013	10 May 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INVESTIGATIONS	HEART RATE INCREASED	MILD	07 May 2013	10 May 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	07 Jun 2013	07 Jun 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	07 Jun 2013	07 Jun 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1286	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	23 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MILD	18 Feb 2014	18 Feb 2014	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	CONSTIPATION	MILD	18 Feb 2014	18 Feb 2014	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	12 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-708-1296	CARDIAC DISORDERS	ATRIAL HYPERTROPHY	MILD	27 Jun 2013	27 Jun 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	ATRIAL HYPERTROPHY	MILD	27 Jun 2013	27 Jun 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	04 Sep 2013	18 Sep 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	04 Sep 2013	18 Sep 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	04 Oct 2013	30 Oct 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	04 Oct 2013	30 Oct 2013	RECOVERED/RESOLVED	PROBABLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	PAIN IN EXTREMITY	MILD	07 Dec 2013	07 Dec 2013	RECOVERED/RESOLVED	REMOTE
01-708-1316	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	15 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	29 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-709-1088	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	08 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	02 Aug 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-709-1259	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PYREXIA	MILD	13 Apr 2013	14 Apr 2013	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	LOCALISED INFECTION	MILD	05 Feb 2013	13 Feb 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	LOCALISED INFECTION	MILD	05 Feb 2013	13 Feb 2013	RECOVERED/RESOLVED	NONE
	INVESTIGATIONS	BLOOD URINE PRESENT	MILD	14 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INVESTIGATIONS	CYSTOSCOPY	MILD	17 Mar 2013	17 Mar 2013	RECOVERED/RESOLVED	NONE
	METABOLISM AND NUTRITION DISORDERS	DEHYDRATION	MILD	13 Apr 2013	14 Apr 2013	RECOVERED/RESOLVED	NONE
	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	BENIGN PROSTATIC HYPERPLASIA	SEVERE	17 Mar 2013	30 Mar 2013	RECOVERED/RESOLVED	NONE
	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	BENIGN PROSTATIC HYPERPLASIA	MILD	17 Mar 2013	30 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	VASCULAR DISORDERS	HYPOTENSION	MILD	13 Apr 2013	14 Apr 2013	RECOVERED/RESOLVED	POSSIBLE
	VASCULAR DISORDERS	ORTHOSTATIC HYPOTENSION	MILD	20 Apr 2013	13 Jun 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	VASCULAR DISORDERS	ORTHOSTATIC HYPOTENSION	MILD	20 Apr 2013	13 Jun 2013	RECOVERED/RESOLVED	POSSIBLE
01-709-1301	METABOLISM AND NUTRITION DISORDERS	DIABETES MELLITUS	MILD	30 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-709-1306	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	04 May 2014	23 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	04 May 2014	23 Jun 2014	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	20 Apr 2014	23 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	20 Apr 2014	23 Jun 2014	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	20 Apr 2014	23 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	DRUG ERUPTION	MILD	20 May 2014	23 May 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	20 Apr 2014	23 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	20 Apr 2014	23 Jun 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	20 Apr 2014	23 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-709-1312	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	17 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	19 Oct 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-709-1339	INVESTIGATIONS	BLOOD ALKALINE PHOSPHATASE INCREASED	MODERATE	12 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-710-1027	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	HAEMOPTYSIS	MILD	09 May 2014	01 Jun 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	HAEMOPTYSIS	MILD	09 May 2014	01 Jun 2014	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RALES	MILD	23 May 2014	20 Jun 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RALES	MILD	23 May 2014	20 Jun 2014	RECOVERED/RESOLVED	NONE
01-710-1060	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE INDURATION	MILD	21 Jan 2013	21 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	23 Jan 2013	23 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	31 Jan 2013	31 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FALL	MILD	08 Feb 2013	08 Feb 2013	RECOVERED/RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FALL	MILD	09 Feb 2013	09 Feb 2013	RECOVERED/RESOLVED	NONE
	PSYCHIATRIC DISORDERS	INSOMNIA	MILD	04 Jan 2013	15 Jan 2013	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	INSOMNIA	MILD	04 Jan 2013	15 Jan 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	02 Jan 2013	02 Jan 2013	RECOVERED/RESOLVED	NONE
01-710-1077	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	12 Dec 2013	12 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	AGITATION	MILD	12 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	27 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1083	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	SEVERE	02 Aug 2013	02 Aug 2013	FATAL	POSSIBLE
01-710-1183	CARDIAC DISORDERS	ATRIOVENTRICULAR BLOCK FIRST DEGREE	MILD	10 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	10 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1264	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	03 Jul 2013	05 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MODERATE	29 Sep 2013	29 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MODERATE	09 Oct 2013	09 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MODERATE	11 Oct 2013	11 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	COLD SWEAT	MODERATE	29 Sep 2013	29 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	COLD SWEAT	MODERATE	09 Oct 2013	09 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	COLD SWEAT	MODERATE	11 Oct 2013	11 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	21 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	21 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1271	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MODERATE	21 Nov 2012	26 Nov 2012	RECOVERED/RESOLVED	POSSIBLE
	CARDIAC DISORDERS	CARDIAC FAILURE CONGESTIVE	MODERATE	22 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	SEVERE	21 Nov 2012	21 Nov 2012	RECOVERED/RESOLVED	POSSIBLE
	METABOLISM AND NUTRITION DISORDERS	HYPONATRAEMIA	MODERATE	22 Nov 2012	26 Nov 2012	RECOVERED/RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	DYSPNOEA	MODERATE	21 Nov 2012	21 Nov 2012	RECOVERED/RESOLVED	POSSIBLE
01-710-1314	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	20 May 2013	24 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	20 May 2013	24 May 2013	RECOVERED/RESOLVED	NONE
01-710-1315	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	18 Jun 2013	07 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	18 Jun 2013	07 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	14 May 2013	07 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	14 May 2013	07 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	18 Jun 2013	07 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	18 Jun 2013	07 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1368	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	HIP FRACTURE	SEVERE	25 Dec 2013	24 Apr 2014	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	HIP FRACTURE	SEVERE	25 Dec 2013	24 Apr 2014	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	PSYCHOMOTOR HYPERACTIVITY	MILD	26 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	PSYCHIATRIC DISORDERS	DELUSION	MILD	26 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-711-1036	GASTROINTESTINAL DISORDERS	GLOSSITIS	MILD	12 Aug 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	EAR INFECTION	MILD	04 Aug 2012	12 Aug 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	EAR INFECTION	MILD	04 Aug 2012	12 Aug 2012	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	29 Jul 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-713-1179	GASTROINTESTINAL DISORDERS	DYSPEPSIA	MILD	22 Aug 2013	22 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	DYSPEPSIA	MILD	12 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	GASTROOESOPHAGEAL REFLUX DISEASE	MILD	10 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	ASTHENIA	MODERATE	05 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	ASTHENIA	MILD	05 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INFECTIONS AND INFESTATIONS	CERVICITIS	MILD	23 Nov 2013	02 Dec 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	CERVICITIS	MILD	23 Nov 2013	02 Dec 2013	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	GASTROENTERITIS VIRAL	MODERATE	10 Oct 2013	13 Oct 2013	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	URINARY TRACT INFECTION	MILD	28 Aug 2013	08 Sep 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	URINARY TRACT INFECTION	MILD	28 Aug 2013	08 Sep 2013	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	VAGINAL MYCOSIS	MILD	23 Nov 2013	02 Dec 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	VAGINAL MYCOSIS	MILD	23 Nov 2013	02 Dec 2013	RECOVERED/RESOLVED	REMOTE
	RENAL AND URINARY DISORDERS	DYSURIA	MILD	19 Aug 2013	23 Aug 2013	RECOVERED/RESOLVED	REMOTE
	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	PELVIC PAIN	MILD	10 Oct 2013	18 Jan 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	PELVIC PAIN	MILD	10 Oct 2013	18 Jan 2014	RECOVERED/RESOLVED	POSSIBLE
01-713-1256	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	30 Oct 2012	31 Oct 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	30 Oct 2012	31 Oct 2012	RECOVERED/RESOLVED	PROBABLE
01-713-1269	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	02 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	SHOULDER PAIN	MODERATE	01 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	SHOULDER PAIN	MILD	01 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	18 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	10 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	10 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-714-1035	CARDIAC DISORDERS	BUNDLE BRANCH BLOCK RIGHT	MILD	26 May 2014	04 Jun 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	BUNDLE BRANCH BLOCK RIGHT	MILD	26 May 2014	04 Jun 2014	RECOVERED/RESOLVED	REMOTE
	CARDIAC DISORDERS	SUPRAVENTRICULAR EXTRASYSTOLES	MILD	04 Jun 2014	17 Jun 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SUPRAVENTRICULAR EXTRASYSTOLES	MILD	04 Jun 2014	17 Jun 2014	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	BRONCHITIS	MODERATE	18 Jul 2014	24 Jul 2014	RECOVERED/RESOLVED	NONE
	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	04 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE INVERSION	MILD	26 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-714-1375	EAR AND LABYRINTH DISORDERS	EAR PAIN	MILD	04 Apr 2013	15 Apr 2013	NOT RECOVERED/NOT RESOLVED	NONE
	EAR AND LABYRINTH DISORDERS	EAR PAIN	MILD	04 Apr 2013	15 Apr 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	16 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	16 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	29 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	29 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	30 Mar 2013	06 Apr 2013	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	30 Mar 2013	06 Apr 2013	RECOVERED/RESOLVED	NONE
01-715-1207	RENAL AND URINARY DISORDERS	NEPHROLITHIASIS	MODERATE	10 Jan 2013	10 Jan 2013	RECOVERED/RESOLVED	NONE
01-716-1024	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MODERATE	20 Aug 2012	27 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MODERATE	20 Aug 2012	27 Sep 2012	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	EMPHYSEMA	MILD	16 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1026	INFECTIONS AND INFESTATIONS	EAR INFECTION	MILD	16 Jul 2014	25 Jul 2014	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	EAR INFECTION	MILD	15 Aug 2014	27 Aug 2014	RECOVERED/RESOLVED	NONE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	MILD	31 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE INVERSION	MILD	18 Apr 2014	31 Jul 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE INVERSION	MILD	18 Apr 2014	31 Jul 2014	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	17 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	17 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-716-1044	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	21 May 2013	26 May 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	21 May 2013	26 May 2013	RECOVERED/RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MILD	15 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-716-1108	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	12 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	01 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1160	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	09 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	09 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1308	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	20 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1441	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	11 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1201	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ALOPECIA	MILD	15 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	19 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1344	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	28 Feb 2014	01 Mar 2014	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	VOMITING	MODERATE	28 Feb 2014	01 Mar 2014	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	01 Feb 2014	18 Feb 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	01 Feb 2014	18 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	01 Feb 2014	06 Feb 2014	RECOVERED/RESOLVED	REMOTE
01-718-1139	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	16 Nov 2013	16 Nov 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	03 Jun 2013	16 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	03 Jun 2013	16 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
01-718-1150	CARDIAC DISORDERS	BRADYCARDIA	MILD	16 Feb 2013	17 Mar 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	BRADYCARDIA	MILD	16 Feb 2013	17 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	CARDIAC DISORDERS	BRADYCARDIA	MILD	10 May 2013	07 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	BRADYCARDIA	MILD	10 May 2013	07 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	31 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	15 Mar 2013	15 Mar 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	16 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MODERATE	06 Mar 2013	26 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MODERATE	06 Mar 2013	26 Mar 2013	RECOVERED/RESOLVED	NONE
	METABOLISM AND NUTRITION DISORDERS	FOOD CRAVING	MILD	09 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-718-1355	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	27 Apr 2013	27 Apr 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	12 May 2013	12 May 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	16 May 2013	16 May 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	20 May 2013	20 May 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE REACTION	MODERATE	23 Jun 2013	13 Aug 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE REACTION	MILD	23 Jun 2013	13 Aug 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	25 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MODERATE	17 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN ULCER	MODERATE	08 Mar 2013	22 Mar 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN ULCER	MODERATE	08 Mar 2013	22 Mar 2013	RECOVERED/RESOLVED	PROBABLE
	VASCULAR DISORDERS	HYPERTENSION	MODERATE	15 Aug 2013	29 Aug 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	VASCULAR DISORDERS	HYPERTENSION	MODERATE	15 Aug 2013	29 Aug 2013	RECOVERED/RESOLVED	REMOTE

TEAE = Treatment-Emergent Adverse Event: onset on or after first dose date.

Outcome: RECOVERED/RESOLVED, RECOVERING/RESOLVING, NOT RECOVERED/NOT RESOLVED, FATAL, UNKNOWN.

Relationship: RELATED, NOT RELATED, POSSIBLY RELATED.

Sorted by treatment arm, subject, system organ class, and preferred term.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:50:44

Listing 16.2.7.1

Listing of Treatment-Emergent Adverse Events

Safety Population

Xanomeline High Dose

Subject ID	System Organ Class	Preferred Term	Severity	Start Date	End Date	Outcome	Relationship to Study Drug
01-701-1028	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	21 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	08 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1034	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	27 Aug 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	02 Nov 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-701-1133	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1146	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	10 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	10 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	26 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	01 Jun 2013	02 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PAIN	MODERATE	22 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	10 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	10 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MODERATE	26 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	03 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-701-1148	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	25 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	25 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	LOWER RESPIRATORY TRACT INFECTION	MODERATE	12 Oct 2013	10 Nov 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	LOWER RESPIRATORY TRACT INFECTION	MODERATE	12 Oct 2013	10 Nov 2013	RECOVERED/RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	FLANK PAIN	MODERATE	15 Dec 2013	17 Dec 2013	RECOVERED/RESOLVED	NONE
	RENAL AND URINARY DISORDERS	CALCULUS URETHRAL	MODERATE	17 Dec 2013	17 Dec 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	EPISTAXIS	MILD	03 Jan 2014	03 Jan 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ACTINIC KERATOSIS	MILD	12 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-701-1180	GASTROINTESTINAL DISORDERS	VOMITING	MILD	12 Feb 2013	12 Feb 2013	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	12 Feb 2013	12 Feb 2013	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	19 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	19 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MODERATE	19 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	06 Mar 2013	07 Mar 2013	RECOVERED/RESOLVED	NONE
	RENAL AND URINARY DISORDERS	MICTURITION URGENCY	MILD	15 Feb 2013	19 Mar 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RENAL AND URINARY DISORDERS	MICTURITION URGENCY	MILD	15 Feb 2013	19 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
01-701-1239	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	20 Jan 2014	08 Feb 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	20 Jan 2014	08 Feb 2014	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	01 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	HORDEOLUM	MILD	01 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	20 Feb 2014	12 Mar 2014	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	20 Feb 2014	12 Mar 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	12 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	12 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	13 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN ODOUR ABNORMAL	MILD	12 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-701-1275	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	13 Feb 2014	03 Jun 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	13 Feb 2014	03 Jun 2014	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	SALIVARY HYPERSECRETION	MILD	24 Feb 2014	03 Jun 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	SALIVARY HYPERSECRETION	MILD	24 Feb 2014	03 Jun 2014	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	23 Feb 2014	23 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	PAROSMIA	MILD	24 Feb 2014	03 Jun 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	PAROSMIA	MILD	24 Feb 2014	03 Jun 2014	RECOVERED/RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	12 Mar 2014	27 Mar 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	12 Mar 2014	27 Mar 2014	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	12 Mar 2014	27 Mar 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	12 Mar 2014	27 Mar 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	24 Feb 2014	12 Jun 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	24 Feb 2014	12 Jun 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	24 Feb 2014	12 Jun 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	24 Feb 2014	12 Jun 2014	RECOVERED/RESOLVED	POSSIBLE
01-701-1287	GASTROINTESTINAL DISORDERS	SALIVARY HYPERSECRETION	MILD	26 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	09 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	22 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RHINORRHOEA	MILD	09 Jul 2014	12 Jul 2014	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RHINORRHOEA	MILD	09 Jul 2014	12 Jul 2014	RECOVERED/RESOLVED	NONE
01-701-1302	GASTROINTESTINAL DISORDERS	STOMACH DISCOMFORT	MILD	30 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	15 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PERSPIRATION	MILD	30 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	15 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FEELING ABNORMAL	MILD	24 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MALAISE	MODERATE	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MALAISE	MILD	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PAIN	MILD	31 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INFECTIONS AND INFESTATIONS	RHINITIS	MILD	23 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	05 Sep 2013	08 Oct 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	05 Sep 2013	08 Oct 2013	RECOVERED/RESOLVED	REMOTE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MYALGIA	MILD	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	02 Sep 2013	03 Sep 2013	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	04 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	15 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	LIBIDO DECREASED	MILD	24 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	LISTLESS	MILD	24 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	EPISTAXIS	MILD	30 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	01 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	PHARYNGOLARYNGEAL PAIN	MILD	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	PRODUCTIVE COUGH	MILD	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RESPIRATORY TRACT CONGESTION	MILD	23 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	30 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-701-1383	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	23 Mar 2013	26 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	12 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	12 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	12 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PAIN	MILD	07 Feb 2013	07 Feb 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	23 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	07 Feb 2013	07 Feb 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	23 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	07 May 2013	24 May 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHEST DISCOMFORT	MILD	24 Jun 2013	24 Jun 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	24 Jun 2013	24 Jun 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MODERATE	17 Jul 2013	26 Jul 2013	RECOVERED/RESOLVED	NONE
01-701-1444	GASTROINTESTINAL DISORDERS	SALIVARY HYPERSECRETION	MILD	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	04 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MODERATE	04 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	PARAESTHESIA	MILD	08 Feb 2013	08 Feb 2013	RECOVERED/RESOLVED	NONE
01-703-1076	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	23 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	23 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	23 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INVESTIGATIONS	BIOPSY PROSTATE	MODERATE	16 Nov 2013	16 Nov 2013	RECOVERED/RESOLVED	NONE
	REPRODUCTIVE SYSTEM AND BREAST DISORDERS	BENIGN PROSTATIC HYPERPLASIA	MODERATE	20 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	25 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-703-1258	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	04 Sep 2012	25 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	04 Sep 2012	25 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	04 Sep 2012	25 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	11 Aug 2012	19 Aug 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	11 Aug 2012	19 Aug 2012	RECOVERED/RESOLVED	NONE
01-703-1295	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRITIS	MODERATE	28 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-703-1439	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	24 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	24 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1008	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	25 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	TRANSIENT ISCHAEMIC ATTACK	SEVERE	21 Feb 2013	21 Feb 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	30 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-704-1017	CARDIAC DISORDERS	CARDIAC DISORDER	MILD	01 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	19 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	CONGENITAL, FAMILIAL AND GENETIC DISORDERS	VENTRICULAR SEPTAL DEFECT	MILD	19 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	INFLUENZA	MILD	01 Nov 2013	08 Nov 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	05 Nov 2013	22 Nov 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	05 Nov 2013	22 Nov 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	05 Nov 2013	22 Nov 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	05 Nov 2013	22 Nov 2013	RECOVERED/RESOLVED	PROBABLE
01-704-1065	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	24 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	ABDOMINAL DISCOMFORT	MILD	26 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	15 Dec 2013	15 Dec 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	09 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	27 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MILD	17 Nov 2013	17 Nov 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MALAISE	MILD	09 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	17 Nov 2013	17 Nov 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	09 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	27 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1074	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	09 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	22 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1093	INVESTIGATIONS	BLOOD GLUCOSE INCREASED	MILD	30 Mar 2013	13 Apr 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INVESTIGATIONS	BLOOD GLUCOSE INCREASED	MILD	30 Mar 2013	13 Apr 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1241	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	DYSPNOEA	MILD	28 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-704-1266	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MILD	08 Nov 2013	06 Dec 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MILD	08 Nov 2013	06 Dec 2013	RECOVERED/RESOLVED	NONE
	CARDIAC DISORDERS	ATRIAL FLUTTER	MILD	27 Oct 2013	08 Nov 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	ATRIAL FLUTTER	MILD	27 Oct 2013	08 Nov 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MILD	15 Nov 2013	14 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MILD	15 Nov 2013	14 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	17 Oct 2013	23 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	17 Oct 2013	23 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	17 Oct 2013	23 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	06 Dec 2013	23 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	06 Dec 2013	23 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	09 Nov 2013	04 Dec 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	09 Nov 2013	04 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	15 Nov 2013	23 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	15 Nov 2013	23 Dec 2013	RECOVERED/RESOLVED	PROBABLE
01-704-1332	NERVOUS SYSTEM DISORDERS	BURNING SENSATION	MILD	03 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	18 Jan 2014	24 Feb 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	18 Jan 2014	24 Feb 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	10 Dec 2013	24 Feb 2014	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	10 Dec 2013	24 Feb 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	10 Dec 2013	24 Feb 2014	NOT RECOVERED/NOT RESOLVED	NONE
01-705-1280	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	20 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-705-1281	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MODERATE	30 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	30 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	30 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-705-1310	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH PRURITIC	MODERATE	14 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	VASCULAR DISORDERS	WOUND HAEMORRHAGE	MODERATE	09 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-706-1049	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	18 Jun 2013	18 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	03 Jun 2013	03 Jun 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1178	CARDIAC DISORDERS	ATRIAL FIBRILLATION	SEVERE	24 Mar 2014	26 Mar 2014	RECOVERED/RESOLVED	POSSIBLE
	CONGENITAL, FAMILIAL AND GENETIC DISORDERS	VENTRICULAR SEPTAL DEFECT	MILD	09 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	09 Mar 2014	06 Apr 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	09 Mar 2014	06 Apr 2014	RECOVERED/RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	CYSTITIS	MILD	24 Mar 2014	28 Mar 2014	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	01 Mar 2014	08 Mar 2014	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	SEVERE	24 Mar 2014	26 Mar 2014	RECOVERED/RESOLVED	POSSIBLE
	SOCIAL CIRCUMSTANCES	ALCOHOL USE	MILD	24 Mar 2014	24 Mar 2014	RECOVERED/RESOLVED	NONE
01-708-1216	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	06 Nov 2012	13 Dec 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	06 Nov 2012	13 Dec 2012	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	06 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE SWELLING	MILD	22 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-708-1336	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	10 Apr 2013	05 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	10 Apr 2013	05 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	12 Jan 2013	12 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	10 Apr 2013	05 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	10 Apr 2013	05 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	18 Dec 2012	18 Dec 2012	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	02 Feb 2013	02 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1347	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	13 Jun 2013	25 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	13 Jun 2013	25 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE SWELLING	MODERATE	13 Jun 2013	25 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE SWELLING	MODERATE	13 Jun 2013	25 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	13 Jun 2013	25 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	13 Jun 2013	25 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	13 Jun 2013	25 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	13 Jun 2013	25 Jun 2013	RECOVERED/RESOLVED	PROBABLE
01-708-1406	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MILD	16 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MILD	16 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-709-1029	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	09 Jan 2013	19 Feb 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	09 Jan 2013	19 Feb 2013	RECOVERED/RESOLVED	NONE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	20 Mar 2013	16 Apr 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	20 Mar 2013	16 Apr 2013	RECOVERED/RESOLVED	NONE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	15 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	20 Mar 2013	16 Apr 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	20 Mar 2013	16 Apr 2013	RECOVERED/RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	12 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	17 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MUSCLE SPASMS	MILD	24 Jan 2013	27 Feb 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MUSCLE SPASMS	MILD	24 Jan 2013	27 Feb 2013	RECOVERED/RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	12 May 2013	19 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	12 May 2013	19 May 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	PHARYNGEAL ERYTHEMA	MILD	12 May 2013	19 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	PHARYNGEAL ERYTHEMA	MILD	12 May 2013	19 May 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	19 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-709-1099	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	12 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	12 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	12 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	12 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	12 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	06 Nov 2013	17 Nov 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	06 Nov 2013	17 Nov 2013	RECOVERED/RESOLVED	NONE
	SURGICAL AND MEDICAL PROCEDURES	ACROCHORDON EXCISION	MILD	23 Mar 2014	23 Mar 2014	RECOVERED/RESOLVED	NONE
01-709-1168	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	06 Sep 2013	11 Oct 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	06 Sep 2013	11 Oct 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	06 Sep 2013	11 Oct 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	06 Sep 2013	11 Oct 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	17 Aug 2013	06 Sep 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	17 Aug 2013	06 Sep 2013	RECOVERED/RESOLVED	PROBABLE
01-709-1238	GASTROINTESTINAL DISORDERS	DIARRHOEA	MODERATE	28 May 2013	28 May 2013	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DISCHARGE	MODERATE	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MODERATE	09 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	HIP FRACTURE	MODERATE	31 May 2013	31 May 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MODERATE	09 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SURGICAL AND MEDICAL PROCEDURES	SKIN LESION EXCISION	MILD	28 Jun 2013	28 Jun 2013	RECOVERED/RESOLVED	NONE
01-709-1309	GASTROINTESTINAL DISORDERS	VOMITING	MILD	19 Jun 2013	19 Jun 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	19 Jun 2013	19 Jun 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	28 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FEELING COLD	MILD	06 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INVESTIGATIONS	BIOPSY	MILD	26 Jun 2013	26 Jun 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	01 Jul 2013	01 Jul 2013	NOT RECOVERED/NOT RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	01 Jul 2013	01 Jul 2013	RECOVERED/RESOLVED	NONE
	PSYCHIATRIC DISORDERS	NIGHTMARE	MILD	19 Jun 2013	20 Jun 2013	RECOVERED/RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	ALLERGIC GRANULOMATOUS ANGIITIS	MILD	04 Jul 2013	04 Jul 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	19 Jun 2013	20 Jun 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH MACULO-PAPULAR	MILD	20 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-710-1006	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	29 Jun 2013	04 Jul 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	29 Jun 2013	04 Jul 2013	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	SALIVARY HYPERSECRETION	MILD	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INFECTIONS AND INFESTATIONS	URINARY TRACT INFECTION	MILD	17 Apr 2013	19 Apr 2013	RECOVERED/RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	08 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FACIAL BONES FRACTURE	MODERATE	08 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FALL	MILD	08 Aug 2013	08 Aug 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	18 Feb 2013	19 Feb 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	16 Apr 2013	16 Apr 2013	RECOVERED/RESOLVED	NONE
	RENAL AND URINARY DISORDERS	NEPHROLITHIASIS	MODERATE	17 Apr 2013	17 Apr 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	18 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	01 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1021	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHEST PAIN	MILD	10 Oct 2013	10 Oct 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	21 Oct 2013	31 Oct 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	21 Oct 2013	31 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1070	CARDIAC DISORDERS	SUPRAVENTRICULAR EXTRASYSTOLES	MILD	06 Oct 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	GASTROINTESTINAL HAEMORRHAGE	SEVERE	05 Feb 2013	10 Feb 2013	RECOVERED/RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	HIP FRACTURE	SEVERE	22 Jan 2013	25 Jan 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	12 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	12 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	12 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-710-1137	EAR AND LABYRINTH DISORDERS	VERTIGO	MODERATE	04 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	13 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	13 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	13 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1142	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MODERATE	19 Oct 2012	19 Oct 2012	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	14 Oct 2012	14 Oct 2012	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	04 Oct 2012	06 Oct 2012	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	04 Oct 2012	06 Oct 2012	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	SYNCOPE VASOVAGAL	MODERATE	19 Oct 2012	19 Oct 2012	RECOVERED/RESOLVED	POSSIBLE
01-710-1187	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	23 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1249	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	23 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	24 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	11 Feb 2014	11 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	18 Feb 2014	18 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
01-710-1278	GASTROINTESTINAL DISORDERS	VOMITING	MILD	02 Mar 2013	02 Mar 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	24 Feb 2013	03 Mar 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	24 Feb 2013	03 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	BURNING SENSATION	MODERATE	24 Feb 2013	26 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MILD	13 Jan 2013	19 Jan 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	07 Feb 2013	03 Mar 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	07 Feb 2013	03 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1354	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	30 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	14 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1408	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	31 Jan 2013	09 Feb 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	31 Jan 2013	09 Feb 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	24 Feb 2013	31 May 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	24 Feb 2013	31 May 2013	RECOVERED/RESOLVED	POSSIBLE
01-711-1012	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	16 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	16 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	16 Apr 2013	02 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	16 Apr 2013	02 May 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	16 Apr 2013	02 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE URTICARIA	MODERATE	29 Apr 2013	01 May 2013	RECOVERED/RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MODERATE	27 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-713-1141	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MODERATE	30 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	PSYCHIATRIC DISORDERS	DELIRIUM	MODERATE	01 Jul 2013	15 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH PRURITIC	MILD	21 Jun 2013	15 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH PRURITIC	MILD	21 Jun 2013	15 Jul 2013	RECOVERED/RESOLVED	PROBABLE
01-713-1209	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MODERATE	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MILD	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	02 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	31 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-714-1288	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	27 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	14 Dec 2013	15 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	22 Jan 2014	25 Jan 2014	RECOVERED/RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MODERATE	08 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MILD	24 Feb 2014	08 Apr 2014	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MILD	24 Feb 2014	08 Apr 2014	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	13 Dec 2013	13 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	22 Jan 2014	25 Jan 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	11 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-715-1319	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	18 Mar 2013	18 Mar 2013	RECOVERED/RESOLVED	NONE
01-715-1321	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	22 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	14 Mar 2014	14 Mar 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	14 Mar 2014	14 Mar 2014	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE REACTION	MODERATE	21 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1071	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	13 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HYPERSOMNIA	MILD	13 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	31 Jul 2013	31 Jul 2013	RECOVERED/RESOLVED	PROBABLE
01-716-1189	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	PROSTATE CANCER	SEVERE	07 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	DELUSION	MODERATE	24 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	HALLUCINATION	MODERATE	24 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	05 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-716-1229	INVESTIGATIONS	BLOOD CHOLESTEROL INCREASED	MILD	06 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	20 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1364	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	02 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	18 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1373	NERVOUS SYSTEM DISORDERS	COGNITIVE DISORDER	MILD	14 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	15 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1418	EYE DISORDERS	VISION BLURRED	MODERATE	01 Jul 2013	04 Oct 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	EYE DISORDERS	VISION BLURRED	MODERATE	01 Jul 2013	04 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MODERATE	01 Jul 2013	26 Sep 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MODERATE	01 Jul 2013	26 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	26 Sep 2013	11 Nov 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	26 Sep 2013	11 Nov 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	05 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	07 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	URTICARIA	MILD	05 May 2013	07 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	URTICARIA	MILD	05 May 2013	07 May 2013	RECOVERED/RESOLVED	PROBABLE
01-716-1447	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHEST PAIN	MILD	05 Apr 2014	09 Apr 2014	RECOVERED/RESOLVED	REMOTE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE INVERSION	MILD	14 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	14 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	01 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	14 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1109	CARDIAC DISORDERS	VENTRICULAR EXTRASYSTOLES	MILD	18 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	METABOLISM AND NUTRITION DISORDERS	INCREASED APPETITE	MILD	29 Jan 2014	16 Jul 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	METABOLISM AND NUTRITION DISORDERS	INCREASED APPETITE	MILD	29 Jan 2014	16 Jul 2014	RECOVERED/RESOLVED	REMOTE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MILD	20 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	PSYCHIATRIC DISORDERS	INSOMNIA	MILD	22 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	15 Feb 2014	17 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS GENERALISED	MILD	04 Mar 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	15 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1174	PSYCHIATRIC DISORDERS	INSOMNIA	MILD	17 Apr 2013	19 Apr 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	03 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	03 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	SEVERE	25 Apr 2013	26 Apr 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	26 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	26 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1357	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	22 Jul 2013	22 Jul 2013	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	VOMITING	MODERATE	07 Jul 2013	08 Jul 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PERSPIRATION	MODERATE	11 Jun 2013	15 Oct 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PERSPIRATION	MODERATE	11 Jun 2013	15 Oct 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MODERATE	29 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	10 Aug 2013	10 Aug 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	23 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	23 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-718-1101	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	06 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	13 Apr 2013	12 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	13 Apr 2013	12 May 2013	RECOVERED/RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	VOMITING	MILD	06 Mar 2013	06 Mar 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	14 Apr 2013	06 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	14 Apr 2013	06 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
01-718-1328	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	23 Mar 2013	25 Mar 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	02 Apr 2013	21 Apr 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	23 Mar 2013	25 Mar 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	02 Apr 2013	21 Apr 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-718-1371	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	09 May 2013	11 May 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	24 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	24 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	09 May 2013	11 May 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	PARTIAL SEIZURES WITH SECONDARY GENERALISATION	SEVERE	02 Jun 2013	05 Jun 2013	RECOVERED/RESOLVED	NONE
	PSYCHIATRIC DISORDERS	HALLUCINATION, VISUAL	MODERATE	02 Jun 2013	03 Jun 2013	RECOVERED/RESOLVED	POSSIBLE
01-718-1427	GASTROINTESTINAL DISORDERS	NAUSEA	SEVERE	21 Jan 2013	24 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	26 Dec 2012	26 Dec 2012	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	03 Jan 2013	09 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	16 Jan 2013	16 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	04 Feb 2013	25 Feb 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	04 Feb 2013	25 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	27 Jan 2013	27 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	29 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	27 Jan 2013	28 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	27 Jan 2013	28 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	METABOLISM AND NUTRITION DISORDERS	DECREASED APPETITE	MODERATE	04 Feb 2013	25 Feb 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	METABOLISM AND NUTRITION DISORDERS	DECREASED APPETITE	MODERATE	04 Feb 2013	25 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MILD	18 Dec 2012	18 Dec 2012	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	AMNESIA	MILD	01 Jan 2013	19 Jan 2013	NOT RECOVERED/NOT RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	AMNESIA	MILD	01 Jan 2013	19 Jan 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	LETHARGY	MODERATE	05 Jan 2013	05 Jan 2013	RECOVERED/RESOLVED	POSSIBLE

TEAE = Treatment-Emergent Adverse Event: onset on or after first dose date.

Outcome: RECOVERED/RESOLVED, RECOVERING/RESOLVING, NOT RECOVERED/NOT RESOLVED, FATAL, UNKNOWN.

Relationship: RELATED, NOT RELATED, POSSIBLY RELATED.

Sorted by treatment arm, subject, system organ class, and preferred term.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:50:44

Listing 16.2.7.1

Listing of Treatment-Emergent Adverse Events

Safety Population

Xanomeline Low Dose

Subject ID	System Organ Class	Preferred Term	Severity	Start Date	End Date	Outcome	Relationship to Study Drug
01-701-1097	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	21 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	21 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	20 Feb 2014	22 Feb 2014	RECOVERED/RESOLVED	PROBABLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	NASAL CONGESTION	MILD	19 Apr 2014	22 Apr 2014	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	PHARYNGOLARYNGEAL PAIN	MILD	19 Apr 2014	22 Apr 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	03 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS GENERALISED	MODERATE	20 Feb 2014	20 Feb 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS GENERALISED	MODERATE	21 Mar 2014	21 Mar 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS GENERALISED	MODERATE	31 Mar 2014	31 Mar 2014	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS GENERALISED	MODERATE	19 Apr 2014	20 Apr 2014	RECOVERED/RESOLVED	POSSIBLE
01-701-1111	INFECTIONS AND INFESTATIONS	CELLULITIS	MODERATE	13 Sep 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MODERATE	13 Sep 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RENAL AND URINARY DISORDERS	MICTURITION URGENCY	MILD	07 Sep 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-701-1115	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	02 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	02 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	26 Dec 2012	26 Dec 2012	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	26 Dec 2012	26 Dec 2012	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	02 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	02 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MODERATE	14 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-701-1181	PSYCHIATRIC DISORDERS	AGITATION	MODERATE	09 Dec 2013	09 Dec 2013	RECOVERED/RESOLVED	NONE
01-701-1188	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE URTICARIA	MILD	21 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	16 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	16 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	16 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	16 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	URTICARIA	MODERATE	04 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	URTICARIA	MILD	04 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	URTICARIA	MILD	21 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1192	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	05 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	05 Dec 2012	16 Dec 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	05 Dec 2012	16 Dec 2012	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	05 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	SECRETION DISCHARGE	MILD	07 Aug 2012	14 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	SECRETION DISCHARGE	MILD	07 Aug 2012	14 Sep 2012	RECOVERED/RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	PNEUMONIA	MODERATE	07 Sep 2012	06 Oct 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	PNEUMONIA	MODERATE	07 Sep 2012	06 Oct 2012	RECOVERED/RESOLVED	NONE
	INVESTIGATIONS	NASAL MUCOSA BIOPSY	MILD	03 Aug 2012	03 Aug 2012	RECOVERED/RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MUSCULAR WEAKNESS	MODERATE	07 Sep 2012	30 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MUSCULAR WEAKNESS	MODERATE	07 Sep 2012	30 Sep 2012	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	07 Aug 2012	14 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	07 Aug 2012	14 Sep 2012	RECOVERED/RESOLVED	NONE
01-701-1211	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	29 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	16 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	SUDDEN DEATH	SEVERE	14 Jan 2013	14 Jan 2013	FATAL	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	JOINT DISLOCATION	MODERATE	21 Nov 2012	21 Nov 2012	RECOVERED/RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	SKIN LACERATION	MILD	09 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	SHOULDER PAIN	MILD	21 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MODERATE	11 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RENAL AND URINARY DISORDERS	INCONTINENCE	MILD	22 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	DYSPNOEA	MODERATE	11 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-701-1294	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	19 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	19 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	19 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	19 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH ERYTHEMATOUS	MODERATE	10 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1317	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	23 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	23 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE URTICARIA	MILD	23 Jun 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	12 Sep 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	PSYCHIATRIC DISORDERS	DEPRESSED MOOD	MODERATE	04 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	DEPRESSED MOOD	MILD	04 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	DYSPHONIA	MILD	03 Nov 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-701-1324	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	22 Oct 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	02 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	25 Dec 2012	16 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	25 Dec 2012	16 Jan 2013	RECOVERED/RESOLVED	PROBABLE
01-701-1341	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	26 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	26 Jan 2013	30 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	26 Jan 2013	30 Jan 2013	RECOVERED/RESOLVED	PROBABLE
01-701-1360	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	02 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	02 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MODERATE	05 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-701-1442	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	10 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-702-1082	GASTROINTESTINAL DISORDERS	RECTAL HAEMORRHAGE	MILD	02 Sep 2013	06 Sep 2013	NOT RECOVERED/NOT RESOLVED	NONE
	GASTROINTESTINAL DISORDERS	RECTAL HAEMORRHAGE	MILD	02 Sep 2013	06 Sep 2013	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	09 Sep 2013	24 Sep 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	12 Oct 2013	31 Oct 2013	RECOVERED/RESOLVED	PROBABLE
01-703-1086	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	SEVERE	13 Sep 2012	02 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	13 Sep 2012	02 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	13 Sep 2012	02 Jan 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	13 Sep 2012	02 Jan 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MILD	09 Oct 2012	15 Oct 2012	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHILLS	MILD	09 Oct 2012	15 Oct 2012	RECOVERED/RESOLVED	POSSIBLE
01-703-1119	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	SEVERE	16 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	16 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	SEVERE	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	04 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-703-1182	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	31 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	31 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	22 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MILD	22 Nov 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-703-1403	GASTROINTESTINAL DISORDERS	DIARRHOEA	MODERATE	13 Dec 2012	14 Dec 2012	RECOVERED/RESOLVED	PROBABLE
	GASTROINTESTINAL DISORDERS	VOMITING	MODERATE	13 Dec 2012	14 Dec 2012	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	CHEST DISCOMFORT	MILD	15 Dec 2012	16 Dec 2012	RECOVERED/RESOLVED	PROBABLE
	INVESTIGATIONS	WEIGHT DECREASED	MODERATE	12 Dec 2012	19 Dec 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INVESTIGATIONS	WEIGHT DECREASED	MODERATE	12 Dec 2012	19 Dec 2012	RECOVERED/RESOLVED	NONE
01-704-1009	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	22 Sep 2013	23 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	05 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MALAISE	MILD	05 Sep 2013	27 Sep 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	MALAISE	MILD	05 Sep 2013	27 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	17 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	14 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-704-1025	CARDIAC DISORDERS	PALPITATIONS	MODERATE	28 Sep 2013	30 Sep 2013	RECOVERED/RESOLVED	REMOTE
	CARDIAC DISORDERS	WOLFF-PARKINSON-WHITE SYNDROME	MILD	25 Oct 2013	29 Nov 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	WOLFF-PARKINSON-WHITE SYNDROME	MILD	25 Oct 2013	29 Nov 2013	RECOVERED/RESOLVED	POSSIBLE
	EAR AND LABYRINTH DISORDERS	VERTIGO	MODERATE	28 Sep 2013	30 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	11 Oct 2013	25 Oct 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INVESTIGATIONS	ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	MILD	11 Oct 2013	25 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
01-704-1114	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA	MILD	23 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	INFLUENZA	MILD	07 Jun 2013	13 Jun 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	21 Feb 2013	23 Feb 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	23 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	23 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1120	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	28 Dec 2013	03 Feb 2014	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	28 Dec 2013	03 Feb 2014	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	27 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	27 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	23 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	23 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1135	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	SEVERE	08 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	08 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED
01-704-1218	INVESTIGATIONS	BLOOD GLUCOSE INCREASED	MILD	30 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-704-1323	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA	MILD	04 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	VIRAL INFECTION	MILD	30 Jul 2013	03 Aug 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	04 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-704-1325	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	23 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-705-1031	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	25 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-705-1199	GASTROINTESTINAL DISORDERS	DYSPEPSIA	MODERATE	17 Sep 2013	29 Sep 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	DYSPEPSIA	MODERATE	17 Sep 2013	29 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
01-705-1292	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	13 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	28 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-705-1393	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MILD	19 Sep 2012	24 Sep 2012	RECOVERED/RESOLVED	REMOTE
	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	COLON CANCER	SEVERE	21 Jan 2013	24 Jan 2013	RECOVERED/RESOLVED	NONE
01-705-1431	PSYCHIATRIC DISORDERS	ANXIETY	MILD	04 Jul 2013	06 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
01-706-1384	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MODERATE	15 Sep 2012	29 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	EXCORIATION	MODERATE	15 Sep 2012	29 Sep 2012	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	15 Sep 2012	29 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	15 Sep 2012	29 Sep 2012	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	23 Sep 2012	29 Sep 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	23 Sep 2012	29 Sep 2012	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	15 Sep 2012	29 Sep 2012	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	15 Sep 2012	29 Sep 2012	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	23 Sep 2012	29 Sep 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	23 Sep 2012	29 Sep 2012	RECOVERED/RESOLVED	PROBABLE
01-708-1019	EYE DISORDERS	VISION BLURRED	MILD	01 Jan 2014	01 Jan 2014	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	01 Jan 2014	01 Jan 2014	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	SEVERE	31 Dec 2013	31 Dec 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	STUPOR	SEVERE	01 Jan 2014	01 Jan 2014	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	TRANSIENT ISCHAEMIC ATTACK	SEVERE	01 Jan 2014	01 Jan 2014	RECOVERED/RESOLVED	POSSIBLE
01-708-1032	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MODERATE	26 Feb 2013	09 Mar 2013	RECOVERED/RESOLVED	PROBABLE
01-708-1084	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	09 Jun 2013	09 Jun 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	09 Jun 2013	09 Jun 2013	RECOVERED/RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	23 Jun 2013	23 Jun 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	23 Jun 2013	23 Jun 2013	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	23 May 2013	23 May 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	23 May 2013	23 May 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1213	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MILD	22 Feb 2013	22 Feb 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MILD	22 Feb 2013	22 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1272	CARDIAC DISORDERS	VENTRICULAR EXTRASYSTOLES	MILD	21 Feb 2013	20 Mar 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	VENTRICULAR EXTRASYSTOLES	MILD	21 Feb 2013	20 Mar 2013	RECOVERED/RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	11 Feb 2013	11 Feb 2013	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	27 Feb 2013	27 Feb 2013	RECOVERED/RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	01 Mar 2013	07 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	01 Mar 2013	07 Mar 2013	RECOVERED/RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	MUSCLE SPASMS	SEVERE	18 Feb 2013	18 Feb 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	07 Mar 2013	07 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	07 Mar 2013	07 Mar 2013	RECOVERED/RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	01 Mar 2013	07 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	01 Mar 2013	07 Mar 2013	RECOVERED/RESOLVED	NONE
	VASCULAR DISORDERS	HOT FLUSH	MILD	19 Mar 2013	19 Mar 2013	RECOVERED/RESOLVED	NONE
01-708-1297	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	08 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	02 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE SWELLING	MILD	02 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-708-1348	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	18 Aug 2013	31 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	MYOCARDIAL INFARCTION	MILD	18 Aug 2013	31 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	01 Dec 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-708-1353	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	18 Aug 2013	10 Sep 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	18 Aug 2013	10 Sep 2013	RECOVERED/RESOLVED	REMOTE
	VASCULAR DISORDERS	HYPOTENSION	MILD	28 Aug 2013	10 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
01-708-1428	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	SEVERE	10 Dec 2013	21 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	10 Dec 2013	21 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	SEVERE	10 Dec 2013	21 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	10 Dec 2013	21 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE WARMTH	SEVERE	10 Dec 2013	21 Dec 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE WARMTH	MODERATE	10 Dec 2013	21 Dec 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	EPISTAXIS	MILD	22 Nov 2013	22 Nov 2013	RECOVERED/RESOLVED	REMOTE
01-709-1007	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	30 Aug 2012	30 Aug 2012	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	SEVERE	21 Aug 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	16 Aug 2012	19 Aug 2012	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	16 Aug 2012	19 Aug 2012	RECOVERED/RESOLVED	PROBABLE
01-709-1020	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MILD	03 Jan 2013	11 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	03 Jan 2013	11 Jan 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	15 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-709-1081	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	OEDEMA PERIPHERAL	MODERATE	01 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	07 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-709-1102	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	11 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	11 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	11 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	11 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE VESICLES	MILD	26 Mar 2013	27 Mar 2013	RECOVERED/RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	20 Mar 2013	26 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
01-709-1217	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	26 Mar 2013	18 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	26 Mar 2013	18 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	26 Mar 2013	18 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE INVERSION	MILD	30 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	06 Mar 2013	06 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	27 Mar 2013	27 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	01 Apr 2013	11 Apr 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	01 Apr 2013	11 Apr 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	HEADACHE	MILD	17 May 2013	18 May 2013	RECOVERED/RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	20 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	27 May 2013	18 Jun 2013	RECOVERED/RESOLVED	PROBABLE
01-709-1285	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	19 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	19 Apr 2013	31 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	19 Apr 2013	31 May 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	19 Apr 2013	31 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	19 Apr 2013	31 May 2013	RECOVERED/RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	HEMIANOPIA HOMONYMOUS	MILD	14 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-709-1326	GASTROINTESTINAL DISORDERS	VOMITING	MILD	21 May 2013	21 May 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE BLEEDING	MODERATE	07 Jun 2013	17 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MILD	01 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	01 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	MILD	21 May 2013	21 May 2013	RECOVERED/RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MILD	12 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-709-1329	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PYREXIA	MILD	25 Aug 2013	25 Aug 2013	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MILD	25 Aug 2013	25 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
01-709-1424	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	07 Mar 2013	07 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1002	NERVOUS SYSTEM DISORDERS	TRANSIENT ISCHAEMIC ATTACK	MILD	16 Jan 2014	20 Jan 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	TRANSIENT ISCHAEMIC ATTACK	MILD	16 Jan 2014	20 Jan 2014	RECOVERED/RESOLVED	REMOTE
01-710-1045	GASTROINTESTINAL DISORDERS	VOMITING	MILD	22 Jun 2013	22 Jun 2013	RECOVERED/RESOLVED	REMOTE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	02 Jul 2013	09 Jul 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	02 Jul 2013	09 Jul 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	03 Aug 2013	17 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	03 Aug 2013	17 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	02 Jul 2013	17 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	02 Jul 2013	17 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	22 Jul 2013	17 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	22 Jul 2013	17 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN EXFOLIATION	MODERATE	13 Aug 2013	17 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN EXFOLIATION	MODERATE	13 Aug 2013	17 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	02 Jul 2013	17 Aug 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	02 Jul 2013	17 Aug 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1053	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	28 Jan 2013	11 Feb 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	28 Jan 2013	11 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	28 Jan 2013	11 Feb 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MODERATE	28 Jan 2013	11 Feb 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1154	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	SEVERE	18 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	18 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1166	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FALL	MODERATE	19 Mar 2013	19 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	SKIN LACERATION	MODERATE	19 Mar 2013	19 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	COMPLEX PARTIAL SEIZURES	MODERATE	19 Mar 2013	20 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	19 Mar 2013	19 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	20 Mar 2013	20 Mar 2013	RECOVERED/RESOLVED	POSSIBLE
01-710-1235	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	29 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	SHOULDER PAIN	MILD	13 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MODERATE	22 Nov 2012	14 Dec 2012	RECOVERED/RESOLVED	NONE
01-710-1270	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	23 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	23 Feb 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1300	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MILD	13 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MODERATE	10 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	10 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	31 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1358	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DESQUAMATION	MILD	24 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	22 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	22 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-710-1385	CARDIAC DISORDERS	ATRIAL FIBRILLATION	MODERATE	18 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	ATRIOVENTRICULAR BLOCK FIRST DEGREE	MILD	26 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	SUPRAVENTRICULAR TACHYCARDIA	MODERATE	12 Nov 2012	13 Nov 2012	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	SUPRAVENTRICULAR TACHYCARDIA	MODERATE	12 Nov 2012	13 Nov 2012	RECOVERED/RESOLVED	NONE
	INVESTIGATIONS	ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	MILD	18 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MILD	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	18 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	27 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-711-1143	CARDIAC DISORDERS	SUPRAVENTRICULAR EXTRASYSTOLES	MILD	29 Apr 2013	15 May 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	SUPRAVENTRICULAR EXTRASYSTOLES	MILD	29 Apr 2013	15 May 2013	RECOVERED/RESOLVED	POSSIBLE
	CARDIAC DISORDERS	VENTRICULAR EXTRASYSTOLES	MODERATE	28 May 2013	01 Jun 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	CARDIAC DISORDERS	VENTRICULAR EXTRASYSTOLES	MODERATE	28 May 2013	01 Jun 2013	RECOVERED/RESOLVED	PROBABLE
	EAR AND LABYRINTH DISORDERS	CERUMEN IMPACTION	MILD	01 Jun 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	EYE DISORDERS	CONJUNCTIVAL HAEMORRHAGE	MODERATE	30 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	MODERATE	18 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	SEVERE	28 Apr 2013	11 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	28 Apr 2013	11 May 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	NASOPHARYNGITIS	MILD	28 Apr 2013	11 May 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	PARAESTHESIA ORAL	MILD	11 Apr 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH PRURITIC	MODERATE	27 May 2013	31 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH PRURITIC	MODERATE	27 May 2013	31 May 2013	RECOVERED/RESOLVED	PROBABLE
01-711-1433	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	ASTHENIA	MODERATE	05 Feb 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
01-713-1043	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	11 Oct 2013	11 Oct 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MODERATE	11 Oct 2013	11 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	VOMITING	MODERATE	11 Oct 2013	11 Oct 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	VOMITING	MODERATE	11 Oct 2013	11 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	26 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	26 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SURGICAL AND MEDICAL PROCEDURES	CATARACT OPERATION	MILD	08 Mar 2014	08 Mar 2014	RECOVERED/RESOLVED	NONE
01-713-1073	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	14 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-713-1448	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	27 Mar 2014	23 May 2014	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GASTROINTESTINAL DISORDERS	NAUSEA	MILD	27 Mar 2014	23 May 2014	RECOVERED/RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	19 Mar 2014	23 May 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	19 Mar 2014	23 May 2014	RECOVERED/RESOLVED	PROBABLE
01-714-1068	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MODERATE	20 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	MILD	20 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	20 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	20 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	12 Aug 2013	22 Aug 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	12 Aug 2013	22 Aug 2013	RECOVERED/RESOLVED	PROBABLE
01-714-1195	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	12 May 2013	17 Jul 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	GASTROINTESTINAL DISORDERS	DIARRHOEA	MILD	12 May 2013	17 Jul 2013	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	SEVERE	13 May 2013	17 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	SEVERE	13 May 2013	17 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	17 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MILD	14 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	RENAL AND URINARY DISORDERS	DYSURIA	MILD	25 Jul 2013	06 Aug 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MODERATE	12 May 2013	17 Jul 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MODERATE	12 May 2013	17 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
01-715-1107	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	13 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	DERMATITIS CONTACT	MODERATE	07 May 2013	21 May 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	DERMATITIS CONTACT	MODERATE	07 May 2013	21 May 2013	RECOVERED/RESOLVED	PROBABLE
01-715-1405	CARDIAC DISORDERS	PALPITATIONS	MODERATE	08 Jul 2013	08 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	13 Jul 2013	13 Jul 2013	NOT RECOVERED/NOT RESOLVED	NONE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MODERATE	13 Jul 2013	13 Jul 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	08 Jul 2013	08 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MODERATE	08 Jul 2013	08 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MODERATE	08 Jul 2013	08 Jul 2013	RECOVERED/RESOLVED	PROBABLE
01-716-1063	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MILD	01 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	LETHARGY	MODERATE	31 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	RESTLESSNESS	MODERATE	28 Jul 2013	31 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	RESTLESSNESS	MODERATE	28 Jul 2013	31 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MILD	09 May 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Jul 2013	28 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	04 Jul 2013	28 Jul 2013	RECOVERED/RESOLVED	PROBABLE
01-716-1094	CARDIAC DISORDERS	ATRIAL FLUTTER	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CARDIAC DISORDERS	BUNDLE BRANCH BLOCK RIGHT	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	CONGENITAL, FAMILIAL AND GENETIC DISORDERS	VENTRICULAR SEPTAL DEFECT	MODERATE	19 Jan 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-716-1103	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	SEVERE	17 Aug 2014	24 Aug 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	SEVERE	17 Aug 2014	24 Aug 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MODERATE	09 Jul 2014	16 Jul 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	09 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	09 Jul 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1151	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MALIGNANT FIBROUS HISTIOCYTOMA	MILD	19 Feb 2013	22 Mar 2013	NOT RECOVERED/NOT RESOLVED	NONE
	NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	MALIGNANT FIBROUS HISTIOCYTOMA	MILD	19 Feb 2013	22 Mar 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	15 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	15 Mar 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1157	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	17 Oct 2013	04 Nov 2013	NOT RECOVERED/NOT RESOLVED	NONE
	INFECTIONS AND INFESTATIONS	UPPER RESPIRATORY TRACT INFECTION	MILD	17 Oct 2013	04 Nov 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	25 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MILD	25 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-716-1167	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	SWELLING	MODERATE	17 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	IMMUNE SYSTEM DISORDERS	HYPERSENSITIVITY	MILD	10 Mar 2013	10 Apr 2013	NOT RECOVERED/NOT RESOLVED	NONE
	IMMUNE SYSTEM DISORDERS	HYPERSENSITIVITY	MILD	10 Mar 2013	10 Apr 2013	RECOVERED/RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MODERATE	03 Dec 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	17 Nov 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
01-716-1298	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MODERATE	08 Jun 2013	06 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	BLISTER	MODERATE	08 Jun 2013	06 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	22 Apr 2013	06 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MODERATE	22 Apr 2013	06 Jul 2013	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	22 Apr 2013	06 Jul 2013	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	PRURITUS	MODERATE	22 Apr 2013	06 Jul 2013	RECOVERED/RESOLVED	PROBABLE
01-716-1311	GASTROINTESTINAL DISORDERS	ABDOMINAL PAIN	MODERATE	22 Jul 2014	02 Aug 2014	RECOVERED/RESOLVED	NONE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	ULCER	MODERATE	02 Aug 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	28 May 2014	22 Sep 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	ERYTHEMA	MILD	28 May 2014	22 Sep 2014	RECOVERED/RESOLVED	PROBABLE
01-717-1004	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	08 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	FATIGUE	MODERATE	15 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	WOUND	MILD	03 Jun 2014	10 Jun 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	WOUND	MILD	03 Jun 2014	10 Jun 2014	RECOVERED/RESOLVED	PROBABLE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	BACK PAIN	MODERATE	21 May 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	PSYCHIATRIC DISORDERS	ANXIETY	MILD	15 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	IRRITABILITY	MILD	15 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MODERATE	15 Jan 2014	18 Feb 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	COUGH	MODERATE	15 Jan 2014	18 Feb 2014	RECOVERED/RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RHINORRHOEA	MILD	15 Jan 2014	08 Feb 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	RHINORRHOEA	MILD	15 Jan 2014	08 Feb 2014	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	15 Jan 2014	09 Feb 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	15 Jan 2014	09 Feb 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	09 Mar 2014	15 Mar 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	09 Mar 2014	15 Mar 2014	RECOVERED/RESOLVED	PROBABLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MILD	21 Apr 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
01-717-1446	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	06 Oct 2013	03 Mar 2014	NOT RECOVERED/NOT RESOLVED	REMOTE
	CARDIAC DISORDERS	SINUS BRADYCARDIA	MILD	06 Oct 2013	03 Mar 2014	RECOVERED/RESOLVED	REMOTE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PAIN	MODERATE	13 Jan 2014	14 Jan 2014	RECOVERED/RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	PAIN	MODERATE	28 Jan 2014	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	ANXIETY	MILD	15 Sep 2013	16 Sep 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	ANXIETY	MILD	15 Sep 2013	16 Sep 2013	RECOVERED/RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	07 Oct 2013	11 Oct 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	RASH	MILD	07 Oct 2013	11 Oct 2013	RECOVERED/RESOLVED	REMOTE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	SKIN IRRITATION	MODERATE	19 Sep 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-718-1066	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	INFLAMMATION	MODERATE	30 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	16 Jul 2013	20 Jul 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	30 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	PSYCHIATRIC DISORDERS	AGITATION	MODERATE	18 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-718-1079	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	SEVERE	05 Oct 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	MODERATE	05 Oct 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	CONFUSIONAL STATE	MODERATE	05 Oct 2012	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
01-718-1170	INVESTIGATIONS	BODY TEMPERATURE INCREASED	MILD	11 Oct 2013	12 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	DIZZINESS	MODERATE	07 Oct 2013	07 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	12 Oct 2013	13 Oct 2013	RECOVERED/RESOLVED	PROBABLE
	PSYCHIATRIC DISORDERS	AGITATION	SEVERE	16 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	SKIN AND SUBCUTANEOUS TISSUE DISORDERS	HYPERHIDROSIS	MODERATE	11 Oct 2013	12 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
	VASCULAR DISORDERS	HYPERTENSION	MILD	11 Oct 2013	12 Oct 2013	RECOVERED/RESOLVED	POSSIBLE
01-718-1250	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	29 Dec 2013	19 Feb 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	29 Dec 2013	19 Feb 2014	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MILD	29 Dec 2013	19 Feb 2014	RECOVERED/RESOLVED	PROBABLE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MODERATE	15 Oct 2013	02 Nov 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	15 Oct 2013	02 Nov 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	CONTUSION	MILD	15 Oct 2013	02 Nov 2013	RECOVERED/RESOLVED	REMOTE
	INJURY, POISONING AND PROCEDURAL COMPLICATIONS	FALL	MILD	09 Oct 2013	09 Oct 2013	RECOVERED/RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	BALANCE DISORDER	MODERATE	09 Oct 2013	15 Nov 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	BALANCE DISORDER	MILD	09 Oct 2013	15 Nov 2013	NOT RECOVERED/NOT RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	BALANCE DISORDER	MILD	09 Oct 2013	15 Nov 2013	RECOVERED/RESOLVED	POSSIBLE
	NERVOUS SYSTEM DISORDERS	COORDINATION ABNORMAL	MILD	15 Nov 2013	15 Nov 2013	RECOVERED/RESOLVED	POSSIBLE
01-718-1254	GASTROINTESTINAL DISORDERS	DYSPHAGIA	MODERATE	31 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DISCOLOURATION	MODERATE	13 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE PRURITUS	MODERATE	13 Aug 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	PROBABLE
	METABOLISM AND NUTRITION DISORDERS	FOOD CRAVING	MODERATE	31 Oct 2013	Ongoing	NOT RECOVERED/NOT RESOLVED
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MODERATE	13 Jul 2013	Ongoing	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MILD	25 Jul 2013	25 Jul 2013	NOT RECOVERED/NOT RESOLVED	NONE
	MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	ARTHRALGIA	MILD	25 Jul 2013	25 Jul 2013	RECOVERED/RESOLVED	NONE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	03 Sep 2013	19 Sep 2013	NOT RECOVERED/NOT RESOLVED	REMOTE
	NERVOUS SYSTEM DISORDERS	SOMNOLENCE	MODERATE	03 Sep 2013	19 Sep 2013	RECOVERED/RESOLVED	REMOTE

TEAE = Treatment-Emergent Adverse Event: onset on or after first dose date.

Outcome: RECOVERED/RESOLVED, RECOVERING/RESOLVING, NOT RECOVERED/NOT RESOLVED, FATAL, UNKNOWN.

Relationship: RELATED, NOT RELATED, POSSIBLY RELATED.

Sorted by treatment arm, subject, system organ class, and preferred term.

/opt/quarto/share/rmd/rmd.R 01APR2026 09:50:44