A Study Of Sunitinib In Combination With Capecitabine Com... | NCT00435409

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
A	Experimental		Drug: Sunitinib + Capecitabine
B	Active Comparator		Drug: Capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib + Capecitabine	Drug	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day [1000 mg/m^2 bid (twice daily)] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.	Baseline until disease progression (up to 3 years from first dose)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR)	Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Downey	California	90241	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23857972	Derived	Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
BG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

Independent radiology assessment

Title	Measurements
	OG0005.5(4.5 to 6.0) OG0015.9(5.4 to 7.6)

Investigator's assessment

Title	Measurements
	OG000

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	A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors	Log Rank		0.9409	Stratification factors included metastatic organ sites (2 or less versus [vs] more than [>] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs >1), from interactive voice response system (IVRS).	Hazard Ratio (HR)	1.2239			2-Sided	95	0.9487	1.5789				No	Superiority or Other

Secondary

Percentage of Participants With Objective Response (OR)

Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.

ITT population

Posted

Number

95% Confidence Interval

percentage of participants

Baseline until response or disease progression (up to 3 years from first dose)

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Secondary

Duration of Response (DR)

Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.

ITT subgroup of participants with a confirmed objective tumor response.

Posted

Median

95% Confidence Interval

months

Baseline until response or disease progression (up to 3 years from first dose)

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Secondary

Overall Survival (OS)

Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.

ITT population

Posted

Median

95% Confidence Interval

months

Baseline until death or up to 3 years from first dose

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Units	Counts

Secondary

Percent Chance of Participant Survival

Probability of survival 2 years and 3 years after the first dose of study treatment.

ITT population

Posted

Number

95% Confidence Interval

probability of survival

Year 1, Year 2, Year 3

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)

EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms

Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.

Posted

Mean

Standard Deviation

score on a scale

Day 1 of each treatment cycle (up to 3 years or end of treatment)

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)

BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

PRO assessments were not analyzed because the study did not meet its primary endpoint.

Posted

Mean

Standard Deviation

Score on a scale

Day 1 of each treatment cycle (up to 3 years or end of treatment)

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Secondary

Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)

EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.

PRO assessments were not analyzed because the study did not meet its primary endpoint.

Posted

Mean

95% Confidence Interval

Score on a scale

Day 1 of each treatment cycle (up to 3 years or end of treatment)

ID	Title	Description
OG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
OG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sunitinib + Capecitabine	Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.			85	217	214	217
EG001	Capecitabine	Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.			59	215	208	215

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0007 affected217 at risk EG0011 affected215 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0007 affected217 at risk EG0010 affected215 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Anal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Ascites	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected217 at risk EG00113 affected215 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0006 affected217 at risk EG0011 affected215 at risk
Pancreatitis haemorrhagic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Peritonitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Subileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0016 affected215 at risk
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG0006 affected217 at risk EG0010 affected215 at risk
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Chills	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Death	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Disease progression	General disorders	MedDRA	Non-systematic Assessment	EG00010 affected217 at risk EG0017 affected215 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
General physical health deterioration	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Malaise	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Mucosal inflammation	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0016 affected215 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Breast infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Erysipelas	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Neutropenic sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Pyelonephritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Tooth infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ejection fraction decreased	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Haemoglobin decreased	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Diabetic coma	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Facial paresis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Neuralgia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Paraplegia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Renal infarct	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Renal pain	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected217 at risk EG0013 affected215 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0008 affected217 at risk EG0012 affected215 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Ureteral catheterisation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Venous thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Ulcer	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
HAEMATEMESIS SECONDARY TO THROMBCYTOPENIA	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG00053 affected217 at risk EG00135 affected215 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG00051 affected217 at risk EG00119 affected215 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG000104 affected217 at risk EG00139 affected215 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG000102 affected217 at risk EG00114 affected215 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG00022 affected217 at risk EG0012 affected215 at risk
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment	EG0004 affected217 at risk EG00116 affected215 at risk
Lacrimation increased	Eye disorders	MedDRA	Non-systematic Assessment	EG00023 affected217 at risk EG00124 affected215 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00038 affected217 at risk EG00129 affected215 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00048 affected217 at risk EG00130 affected215 at risk
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00041 affected217 at risk EG00142 affected215 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG000121 affected217 at risk EG00195 affected215 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00019 affected217 at risk EG00116 affected215 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00038 affected217 at risk EG00113 affected215 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00013 affected217 at risk EG0011 affected215 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00013 affected217 at risk EG00111 affected215 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00012 affected217 at risk EG0015 affected215 at risk
Gingivitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0012 affected215 at risk
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG000122 affected217 at risk EG00191 affected215 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00014 affected217 at risk EG0012 affected215 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00061 affected217 at risk EG00126 affected215 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00090 affected217 at risk EG00155 affected215 at risk
Asthenia	General disorders	MedDRA	Non-systematic Assessment	EG00075 affected217 at risk EG00149 affected215 at risk
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG00012 affected217 at risk EG00112 affected215 at risk
Fatigue	General disorders	MedDRA	Non-systematic Assessment	EG00065 affected217 at risk EG00153 affected215 at risk
Mucosal inflammation	General disorders	MedDRA	Non-systematic Assessment	EG00049 affected217 at risk EG00124 affected215 at risk
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment	EG00016 affected217 at risk EG00119 affected215 at risk
Pain	General disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0018 affected215 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG00021 affected217 at risk EG00115 affected215 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG00013 affected217 at risk EG00113 affected215 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0010 affected215 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00016 affected217 at risk EG00110 affected215 at risk
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected217 at risk EG00113 affected215 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00016 affected217 at risk EG00111 affected215 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG00115 affected215 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment	EG00019 affected217 at risk EG00113 affected215 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Non-systematic Assessment	EG00012 affected217 at risk EG0018 affected215 at risk
Platelet count decreased	Investigations	MedDRA	Non-systematic Assessment	EG00015 affected217 at risk EG0014 affected215 at risk
Weight decreased	Investigations	MedDRA	Non-systematic Assessment	EG00020 affected217 at risk EG00117 affected215 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG00067 affected217 at risk EG00144 affected215 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0018 affected215 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00024 affected217 at risk EG00125 affected215 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00025 affected217 at risk EG00123 affected215 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00013 affected217 at risk EG00112 affected215 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00013 affected217 at risk EG00113 affected215 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00019 affected217 at risk EG0017 affected215 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG00025 affected217 at risk EG00133 affected215 at risk
Dizziness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00014 affected217 at risk EG0019 affected215 at risk
Dysgeusia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00058 affected217 at risk EG00118 affected215 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00057 affected217 at risk EG00132 affected215 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0009 affected217 at risk EG00113 affected215 at risk
Paraesthesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00015 affected217 at risk EG00116 affected215 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00016 affected217 at risk EG0016 affected215 at risk
Anxiety	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG00014 affected217 at risk EG00110 affected215 at risk
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG00018 affected217 at risk EG00120 affected215 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00030 affected217 at risk EG00128 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00031 affected217 at risk EG00126 affected215 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00031 affected217 at risk EG00110 affected215 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00016 affected217 at risk EG00112 affected215 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00014 affected217 at risk EG00116 affected215 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00015 affected217 at risk EG00112 affected215 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00014 affected217 at risk EG00119 affected215 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG000118 affected217 at risk EG001131 affected215 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00018 affected217 at risk EG00124 affected215 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected217 at risk EG00112 affected215 at risk
Hot flush	Vascular disorders	MedDRA	Non-systematic Assessment	EG00011 affected217 at risk EG0016 affected215 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG00046 affected217 at risk EG0018 affected215 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0010 affected215 at risk
Macrocytosis	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Cardiac disorder	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Cyanosis	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0011 affected215 at risk
Palpitations	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0011 affected215 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Pericarditis	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0014 affected215 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0013 affected215 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG00113 affected215 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Conjunctival irritation	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Diplopia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Dry eye	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0014 affected215 at risk
Exophthalmos	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Eye disorder	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Eye inflammation	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Eye irritation	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0017 affected215 at risk
Eye oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Eye pain	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Eye swelling	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Eyelash discolouration	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Eyelid oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0010 affected215 at risk
Eyelid ptosis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Keratitis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Mydriasis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ocular discomfort	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ocular hyperaemia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ocular icterus	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Periorbital oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Photophobia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Retinal disorder	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Visual acuity reduced	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Visual impairment	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0011 affected215 at risk
Vitreous floaters	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Xerophthalmia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Abdominal distension	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0014 affected215 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0015 affected215 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0012 affected215 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Dental caries	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Eructation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Gastrointestinal hypermotility	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0011 affected215 at risk
Gingival disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gingival oedema	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0011 affected215 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Glossitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0010 affected215 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0017 affected215 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ileitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Lip dry	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Lip haematoma	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Lip pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Loose tooth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0011 affected215 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Oedema mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Oesophageal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Oral mucosal eruption	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Oral mucosal erythema	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0010 affected215 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Proctitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0012 affected215 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Sensitivity of teeth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0012 affected215 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Axillary pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0013 affected215 at risk
Catheter site pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Catheter site rash	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Chest discomfort	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0013 affected215 at risk
Condition aggravated	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Disease progression	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Face oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0012 affected215 at risk
Feeling abnormal	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Feeling cold	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Feeling hot	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gait disturbance	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
General physical health deterioration	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0013 affected215 at risk
Hyperthermia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Induration	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Inflammation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Influenza like illness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0016 affected215 at risk
Infusion site extravasation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Injection site thrombosis	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Local swelling	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Localised oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Malaise	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Mass	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Nodule	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0012 affected215 at risk
Secretion discharge	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Swelling	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Temperature intolerance	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Thirst	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ulcer	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Xerosis	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0013 affected215 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Seasonal allergy	Immune system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0017 affected215 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Clostridial infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0016 affected215 at risk
Device related infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Ear infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Erysipelas	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Escherichia infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Eye infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Folliculitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0015 affected215 at risk
Herpes simplex	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0013 affected215 at risk
Herpes virus infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Infected skin ulcer	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Influenza	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0017 affected215 at risk
Laryngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0013 affected215 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0014 affected215 at risk
Lung infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lymphangitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Nail bed infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Nail infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Onychomycosis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Oral fungal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Oral herpes	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Oral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Otitis media	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Paronychia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Pharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0015 affected215 at risk
Puncture site infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rectal abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Skin infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tinea pedis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Tooth abscess	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0014 affected215 at risk
Tooth infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Tracheitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Vaginal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Vulvovaginitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Wound infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Whiplash injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Blood albumin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Blood bilirubin increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0013 affected215 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Blood glucose increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Blood iron increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Blood phosphorus decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Blood potassium decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Blood pressure decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Blood pressure increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0014 affected215 at risk
Blood uric acid increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Breath sounds abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ejection fraction decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0013 affected215 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Haemoglobin	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Heart rate increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Liver function test abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Neutrophil count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0011 affected215 at risk
Protein total increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Respiratory rate increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Thyroid function test abnormal	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Transaminases increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Weight increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0015 affected215 at risk
White blood cell count decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0012 affected215 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0018 affected215 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0010 affected215 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0013 affected215 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0019 affected215 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0013 affected215 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0012 affected215 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0014 affected215 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0015 affected215 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0014 affected215 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Tetany	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0013 affected215 at risk
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG00110 affected215 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0013 affected215 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0017 affected215 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected217 at risk EG00110 affected215 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0012 affected215 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Balance disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Burning sensation	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Cervical root pain	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Coma	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Convulsion	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Coordination abnormal	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Dysaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0018 affected215 at risk
Formication	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Hypersomnia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0016 affected215 at risk
Hypogeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hypokinesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lethargy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Memory impairment	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0014 affected215 at risk
Migraine	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0012 affected215 at risk
Neuralgia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Neurotoxicity	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Paresis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0012 affected215 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0013 affected215 at risk
Presyncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Radicular syndrome	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Radiculitis lumbosacral	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Sciatica	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0014 affected215 at risk
Sensory disturbance	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Sensory loss	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0012 affected215 at risk
Speech disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tremor	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Trigeminal nerve disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Apathy	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0012 affected215 at risk
Delirium	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0014 affected215 at risk
Disorientation	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Emotional disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Emotional distress	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Mood altered	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Nervousness	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Restlessness	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Sleep disorder	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Stress	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Azotaemia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0012 affected215 at risk
Chromaturia	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0013 affected215 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0010 affected215 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Polyuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Renal colic	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Renal pain	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Urge incontinence	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Breast discharge	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Breast induration	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Breast oedema	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0018 affected215 at risk
Breast swelling	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0011 affected215 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Retracted nipple	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Vulvovaginal discomfort	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0012 affected215 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0016 affected215 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0014 affected215 at risk
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Oropharyngeal blistering	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0014 affected215 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0016 affected215 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0013 affected215 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected217 at risk EG0018 affected215 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected217 at risk EG0010 affected215 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0010 affected215 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Hyperkeratosis palmaris and plantaris	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypertrichosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Hypoaesthesia facial	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lipoatrophy	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0013 affected215 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Plantar erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected217 at risk EG0017 affected215 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0012 affected215 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG0011 affected215 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Skin chapped	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Skin depigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected217 at risk EG0012 affected215 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0013 affected215 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0013 affected215 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0011 affected215 at risk
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected217 at risk EG0010 affected215 at risk
Inadequate diet	Social circumstances	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Breast reconstruction	Surgical and medical procedures	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Capillary fragility	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Circulatory collapse	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0014 affected215 at risk
Flushing	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected217 at risk EG0010 affected215 at risk
Hyperaemia	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0019 affected215 at risk
Intermittent claudication	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Lymphoedema	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected217 at risk EG00110 affected215 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Pallor	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0013 affected215 at risk
Phlebitis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0012 affected215 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected217 at risk EG0010 affected215 at risk
Trousseau's syndrome	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0011 affected215 at risk
Vasoconstriction	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected217 at risk EG0010 affected215 at risk
Venous insufficiency	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0000 affected217 at risk EG0011 affected215 at risk

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases