Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras... | NCT01693068

ID	Type	Description	Link
2012-002669-37	EudraCT Number

Status Module

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Label	Type	Description	Intervention Names
Pimasertib	Experimental		Drug: Pimasertib
Dacarbazine	Active Comparator		Drug: Dacarbazine

Name	Type	Description	Arm Group Labels	Other Names
Pimasertib	Drug	Subjects will receive pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment will consist of repeated 21-day cycles which will continue until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with measurable, histologically or cytologically confirmed, locally advanced or metastatic cutaneous melanoma (stage III c or M1ac) N-Ras mutated. If N-Ras mutational status is unknown at screening, it must be prospectively defined before inclusion. If N-Ras mutational status is already known before screening, it must be retrospectively confirmed after inclusion by the sponsor.
Tumor lesions amenable to biopsy or available tumor tissue as archival samples.
Age greater than or equal to (>=) 18 years.
Has read and understood the informed consent form and is willing and able to give informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments.
Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential are defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile".
Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to, during and four weeks after the last dose of trial medication. Effective contraception is defined as the method of contraception with a failure rate of less than 1% per year. Adequate contraception is defined as follows: two barrier methods or one barrier method with a spermicidal or intrauterine device or oral contraception for female partners of male subjects.

Exclusion Criteria:

Has previous systemic treatment for locally advanced or metastatic cutaneous melanoma (excluding adjuvant treatment).
Has non-measurable lesions, disease not evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
Has an Eastern Cooperative Oncology Group performance status (ECOG PS) >1.
Has bone marrow impairment as evidenced by Hemoglobin <10.0 g/dL, Neutrophil count <1.5 * 10^9/L, platelets <100 * 10^9/L.
Has renal impairment as evidenced by calculated creatinine clearance <60 mL/min (according to the Cockcroft-Gault formula).
Has liver function abnormality as defined by total bilirubin >1.5 * Upper Limit of Normal (ULN), or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >2.5 * ULN, for subjects with liver involvement AST/ALT >5 * ULN.
Has significant cardiac conduction abnormalities, including QTc prolongation of >480 milliseconds and/or pacemaker or clinically relevant impaired cardiovascular function.
Has hypertension uncontrolled by medication
Has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for RVO (e.g., uncontrolled glaucoma or ocular hypertension).
Has known active central nervous system (CNS) metastases unless previously radiotherapy treated, stable by CT scan for at least 3 months without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
Has undergone surgical intervention within 28 days from Day 1 of trial drug treatment.
Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years from Day 1 of trial drug treatment.
Has history of any other significant medical disease such as major gastric or small bowel surgery, recent drainage of significant volumes of ascites or pleural effusion or has a psychiatric condition that might impair the subject well-being or preclude full participation in the trial.
Has known hypersensitivity to dacarbazine.
Is a pregnant or nursing female.
Participated in another clinical trial within the past 28 days.
Has creatine phosphokinase (CPK) level at baseline National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=2 (i.e > 2.5 * ULN), and/or has a previous history of myositis or rhabdomyolysis.
Is suitable for treatment with an approved B-Raf inhibitor (exclusion criteria implemented in German amendment only).

Name	Affiliation	Role
Study Director	EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

PubMed Identifier	Type	Citation	Retractions
32610581	Derived	Lebbe C, Dutriaux C, Lesimple T, Kruit W, Kerger J, Thomas L, Guillot B, Braud F, Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert C, Vasey P, Conry R, Isaacs R, Espinosa E, Schueler A, Massimini G, Dreno B. Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover. Cancers (Basel). 2020 Jun 29;12(7):1727. doi: 10.3390/cancers12071727.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Median

95% Confidence Interval

weeks

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Units	Counts
Participants	OG00064 OG001130

Title

Denominators

Categories

Title	Measurements
	OG0006.86(6.00 to 12.14) OG00113.00(12.29 to 17.71)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Log Rank Test		0.0022		Hazard Ratio (HR)	0.59			2-Sided	95	0.42	0.83			The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.		Other	A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system [IVRS] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.

Secondary

Objective Response Rate (ORR)

ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions.

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Number

95% Confidence Interval

percentage of subjects

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Secondary

Disease Control Rate (DCR)

DCR was defined as the percentage of subjects with CR, PR, or stable disease (SD) for greater than (>) 3 months assessed by investigator according to RECIST version 1.1. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Number

95% Confidence Interval

percentage of subjects

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib

Secondary

Percentage of Subjects With Progression-free Survival (PFS) at 6 Months

PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of Subjects with PFS at 6 Months were reported.

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Number

95% Confidence Interval

percentage of subjects

6 months

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Secondary

Overall Survival (OS)

OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date.

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Median

95% Confidence Interval

months

From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Secondary

Percentage of Subjects With Overall Survival (OS) at 12 Months

ITT analysis set included all subjects who were randomized to trial treatment.

Posted

Number

95% Confidence Interval

percentage of subjects

12 months

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Secondary

Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)

QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes 27-item FACT-General (FACT-G) questionnaire which consists of 24 questions;7 relating to physical well-being (PWB),7 relating to social/family well-being (SWB),6 relating to emotional well-being (EWB) and 7 relating to functional well-being (FWB). Also, it includes melanoma-specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life.

ITT analysis set. Here "Number of Subjects Analyzed" = subjects evaluable for this outcome and "Number Analyzed" = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])

ID	Title	Description
OG000	Dacarbazine

Secondary

Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)

QoL assessed using FACT-M assessment tool. This includes 27-item FACT-G questionnaire which consists of 24 questions; 7 relating to PWB, 7 relating to SWB, 6 relating to EWB and 7 relating to FWB. Also, it includes melanoma-specific subscale consists of 16 questions for MS and 8 questions for the MSS. Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Trial Outcome Index (FACT-M TOI) ranges from 0 to a high of 120 and is derived as: FACT-M TOI = PWB Score + FWB Score +MS Score. Higher scores represent a better quality of life.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.

Secondary

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death

AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. TEAEs were to be reported separately for dacarbazine, pimasertib and pimasertib (crossover) reporting arms.

Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

Posted

Number

subjects

Baseline up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.

Secondary

Number of Subjects With Adverse Events (AEs) of Special Interest

Adverse events of special interest included ocular retinal vein occlusion, serious retinal detachment or similar retinal abnormality characterized by accumulation of serous fluid in the retina, creatine phosphokinase (CPK) elevation and isoenzyme TEAE of Special Interest (Grade >=2) and acute renal failure (Grade >=2). Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

Posted

Number

subjects

Baseline up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Secondary

Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings

Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.

Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.

Posted

Number

subjects

Baseline up to cut-off date (04-Jul-2015)

ID	Title	Description
OG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
OG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.	12	61	59	61
EG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.	74	130	130	130
EG002	Pimasertib (Crossover)	Subjects who were randomized and received dacarbazine and were allowed to crossover to pimasertib treatment on progression of their disease.	26	41	41	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Cor pulmonale acute	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pericarditis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Chorioretinopathy	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Cystoid macular oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Macular detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Macular oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Retinal detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Retinal vein occlusion	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Ulcerative keratitis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0016 affected130 at risk EG0021 affected41 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Chills	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cyst rupture	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Disease progression	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0024 affected41 at risk
Impaired healing	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Malaise	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Necrosis	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Sudden death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Bacteraemia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Candida infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Catheter site infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Device related infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0017 affected130 at risk EG0021 affected41 at risk
Infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Localised infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Skin infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00126 affected130 at risk EG0028 affected41 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Ejection fraction decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Lipase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Troponin increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ataxia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Epilepsy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Neuralgia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0020 affected41 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0008 affected61 at risk EG00113 affected130 at risk EG0023 affected41 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00012 affected61 at risk EG0018 affected130 at risk EG0023 affected41 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00013 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0019 affected130 at risk EG0022 affected41 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0006 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Retinal detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00156 affected130 at risk EG00215 affected41 at risk
Vision blurred	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00129 affected130 at risk EG0029 affected41 at risk
Eyelid oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG00118 affected130 at risk EG0022 affected41 at risk
Visual impairment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00112 affected130 at risk EG0022 affected41 at risk
Periorbital oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00112 affected130 at risk EG0021 affected41 at risk
Macular detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00110 affected130 at risk EG0022 affected41 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00010 affected61 at risk EG001106 affected130 at risk EG00231 affected41 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00025 affected61 at risk EG00147 affected130 at risk EG00217 affected41 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00014 affected61 at risk EG00130 affected130 at risk EG00216 affected41 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00021 affected61 at risk EG00124 affected130 at risk EG0027 affected41 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00010 affected61 at risk EG00131 affected130 at risk EG0027 affected41 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG00120 affected130 at risk EG0028 affected41 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00121 affected130 at risk EG0024 affected41 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00111 affected130 at risk EG0023 affected41 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0015 affected130 at risk EG0022 affected41 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0018 affected130 at risk EG0021 affected41 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0017 affected130 at risk EG0021 affected41 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0006 affected61 at risk EG00159 affected130 at risk EG00218 affected41 at risk
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00023 affected61 at risk EG00139 affected130 at risk EG00211 affected41 at risk
Asthenia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00013 affected61 at risk EG00139 affected130 at risk EG00210 affected41 at risk
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected61 at risk EG00127 affected130 at risk EG00210 affected41 at risk
Chills	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00111 affected130 at risk EG0023 affected41 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00186 affected130 at risk EG00228 affected41 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00117 affected130 at risk EG0024 affected41 at risk
Ejection fraction decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00113 affected130 at risk EG0023 affected41 at risk
Weight decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0018 affected130 at risk EG0023 affected41 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0004 affected61 at risk EG0016 affected130 at risk EG0021 affected41 at risk
Weight increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0019 affected130 at risk EG0022 affected41 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0015 affected130 at risk EG0023 affected41 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0014 affected130 at risk EG0023 affected41 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0008 affected61 at risk EG00122 affected130 at risk EG0027 affected41 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00113 affected130 at risk EG0025 affected41 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00110 affected130 at risk EG0022 affected41 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0023 affected41 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0017 affected130 at risk EG0020 affected41 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected61 at risk EG00118 affected130 at risk EG0024 affected41 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0019 affected130 at risk EG0027 affected41 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0018 affected130 at risk EG0028 affected41 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0019 affected130 at risk EG0026 affected41 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0018 affected130 at risk EG0021 affected41 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0024 affected41 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG00117 affected130 at risk EG0025 affected41 at risk
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0008 affected61 at risk EG00116 affected130 at risk EG0020 affected41 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0006 affected61 at risk EG00111 affected130 at risk EG0024 affected41 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0009 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Sciatica	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0015 affected130 at risk EG0023 affected41 at risk
Dysaesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected61 at risk EG00146 affected130 at risk EG00218 affected41 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00147 affected130 at risk EG0029 affected41 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG00117 affected130 at risk EG0027 affected41 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG00114 affected130 at risk EG0024 affected41 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00117 affected130 at risk EG0022 affected41 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG00113 affected130 at risk EG0024 affected41 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00112 affected130 at risk EG0026 affected41 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG00111 affected130 at risk EG0023 affected41 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0018 affected130 at risk EG0021 affected41 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0023 affected41 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Aortic valve disease	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Atrioventricular block	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Bundle branch block	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Bundle branch block right	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Mitral valve sclerosis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0024 affected41 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Optic nerve hypoplasia	Congenital, familial and genetic disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ear congestion	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Blepharitis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blindness	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Cataract	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Chalazion	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Chorioretinopathy	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Chromatopsia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Colour blindness acquired	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Conjunctival oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Cystoid macular oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Deposit eye	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Detachment of retinal pigment epithelium	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Diplopia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dry eye	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0015 affected130 at risk EG0020 affected41 at risk
Erythema of eyelid	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eye discharge	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eye disorder	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Eye haemorrhage	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eye inflammation	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eye oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eye pain	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Eye pruritus	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Eye swelling	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Eyelid haematoma	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Eyelid ptosis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Glaucoma	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lacrimation increased	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Macular cyst	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Macular degeneration	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Macular fibrosis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Macular oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0016 affected130 at risk EG0021 affected41 at risk
Myopia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ocular hyperaemia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ocular hypertension	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Optic disc haemorrhage	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Photophobia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Photopsia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Presbyopia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Retinal deposits	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Retinal disorder	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Retinal haemorrhage	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Retinal oedema	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Retinal pigment epitheliopathy	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Retinal vein occlusion	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Retinopathy	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Subretinal fluid	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Visual acuity reduced	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0020 affected41 at risk
Vitreous detachment	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Vitreous floaters	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Xerophthalmia	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Anal polyp	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Aptyalism	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Ascites	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0015 affected130 at risk EG0022 affected41 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Flatulence	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Glossitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lip dry	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lip oedema	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Lip pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Melaena	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Mouth swelling	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral mucosal eruption	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral mucosal erythema	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oral toxicity	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Regurgitation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tongue disorder	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Axillary pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Catheter site pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Chest discomfort	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Crying	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Disease progression	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Drug intolerance	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Enanthema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Face oedema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG00112 affected130 at risk EG0029 affected41 at risk
Facial pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Feeling cold	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Gait disturbance	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Generalised oedema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperpyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperthermia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Hypothermia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Inflammation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Influenza like illness	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Injection site haematoma	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Localised oedema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Malaise	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0015 affected130 at risk EG0022 affected41 at risk
Mucosal dryness	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Oedema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Papillitis	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Peripheral swelling	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0022 affected41 at risk
Secretion discharge	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Sensation of foreign body	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Temperature intolerance	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Vessel puncture site haematoma	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Vessel puncture site inflammation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Vessel puncture site pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Xerosis	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0022 affected41 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0017 affected130 at risk EG0020 affected41 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Sarcoidosis	Immune system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Abscess limb	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Acute sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Acute tonsillitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Bacterial infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0022 affected41 at risk
Cholangitis infective	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0018 affected130 at risk EG0020 affected41 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Enterobacter infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Folliculitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG00117 affected130 at risk EG0027 affected41 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Fungal skin infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Furuncle	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Helicobacter infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Herpes simplex	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Herpes virus infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Herpes zoster	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Impetigo	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Infected bites	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Influenza	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Klebsiella infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Laryngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Localised infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Lymph gland infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0018 affected130 at risk EG0022 affected41 at risk
Oral candidiasis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Oral fungal infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Oral herpes	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Paronychia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0019 affected130 at risk EG0023 affected41 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pseudomonas infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Pulpitis dental	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash pustular	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG00116 affected130 at risk EG0023 affected41 at risk
Rhinitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0022 affected41 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Skin candida	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Skin infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Superinfection viral	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tinea cruris	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Tinea pedis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tinea versicolour	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Tonsillitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Tooth abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Trichophytosis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0017 affected130 at risk EG0020 affected41 at risk
Vaginal infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Wound infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Optic nerve injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Traumatic shock	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Amylase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Blood albumin decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Blood bicarbonate decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Blood bilirubin increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Blood fibrinogen decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Blood phosphorus increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blood potassium increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Blood pressure increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Blood urea increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Body temperature increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Breath sounds abnormal	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
C-reactive protein increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Electrocardiogram repolarisation abnormality	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
International normalised ratio increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Intraocular pressure increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Lipase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0022 affected41 at risk
Lymphocyte count decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0020 affected41 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Oxygen saturation decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Platelet count decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0016 affected130 at risk EG0021 affected41 at risk
Protein total decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Protein total increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pupillary light reflex tests abnormal	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Troponin increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
White blood cell count decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
White blood cell count increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cell death	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0020 affected41 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Oligodipsia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Blepharal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Ageusia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Amnesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Aphasia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Ataxia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Balance disorder	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cognitive disorder	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dizziness postural	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Dysarthria	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0022 affected41 at risk
Lethargy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Memory impairment	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Migraine	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Motor dysfunction	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Myasthenic syndrome	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Neurotoxicity	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Sensorimotor disorder	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Sensory disturbance	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Somnolence	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0016 affected130 at risk EG0021 affected41 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Tremor	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Visual field defect	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Agitation	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0006 affected61 at risk EG0013 affected130 at risk EG0022 affected41 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Depressed mood	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dyssomnia	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Euphoric mood	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hallucination	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected61 at risk EG0017 affected130 at risk EG0021 affected41 at risk
Irritability	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Mood altered	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Nervousness	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Nightmare	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Persecutory delusion	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Psychomotor retardation	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0022 affected41 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0018 affected130 at risk EG0021 affected41 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Oliguria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Renal injury	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Renal vein occlusion	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Genital discomfort	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Genital erythema	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Scrotal haematocoele	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected61 at risk EG0019 affected130 at risk EG0023 affected41 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected61 at risk EG00126 affected130 at risk EG0026 affected41 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0018 affected130 at risk EG0022 affected41 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0023 affected41 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0022 affected41 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0021 affected41 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0022 affected41 at risk
Diffuse alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Erythrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0016 affected130 at risk EG0020 affected41 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0013 affected130 at risk EG0020 affected41 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0015 affected130 at risk EG0021 affected41 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Rash morbilliform	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0021 affected41 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0014 affected130 at risk EG0021 affected41 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0014 affected130 at risk EG0020 affected41 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0012 affected130 at risk EG0020 affected41 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Diastolic hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Flushing	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0011 affected130 at risk EG0021 affected41 at risk
Haematoma	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Hot flush	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG00121 affected130 at risk EG0026 affected41 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected61 at risk EG0014 affected130 at risk EG0022 affected41 at risk
Lymphoedema	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected61 at risk EG00111 affected130 at risk EG0023 affected41 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Peripheral coldness	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Peripheral venous disease	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Phlebitis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0010 affected130 at risk EG0021 affected41 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk
Vascular compression	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected61 at risk EG0010 affected130 at risk EG0020 affected41 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected61 at risk EG0011 affected130 at risk EG0020 affected41 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Dacarbazine	Subjects received dacarbazine intravenously at dose of 1000 mg/m^2 of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first. Eligible subjects with documented tumor progression on dacarbazine were offered to switch to pimasertib treatment.
BG001	Pimasertib	Subjects received pimasertib orally as monotherapy at a dose of 60 mg twice daily continuously. Treatment consisted of repeated 21-day cycles which was continued until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurred first.
BG002	Total	Total of all reporting groups

ID	Term
C550600	N-(2,3-dihydroxypropyl)-1-((2-fluoro-4-iodophenyl)amino)isonicotinamide
D003606	Dacarbazine