Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCL... | NCT01450761

NCT01450761

ID	Type	Description	Link
2011-000850-48	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ipilimumab+Etoposide+Cisplatin/Carboplatin	Experimental	Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses	Biological: Ipilimumab Drug: Etoposide Drug: Cisplatin Drug: Carboplatin
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Placebo Comparator	Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses	Biological: Placebo matching Ipilimumab Drug: Etoposide Drug: Cisplatin Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Ipilimumab	Biological		Ipilimumab+Etoposide+Cisplatin/Carboplatin	Yervoy BMS-734016

Measure	Description	Time Frame
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	Randomization until date of death, up to March 2015, approximately 38 months

Measure	Description	Time Frame
Overall Survival in All Randomized Participants	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	From randomization until date of death, up to March 2015, approximately 38 months

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Genesis Cancer Center		Hot Springs	Arkansas	71913	United States
Sutter Medical Center

PubMed Identifier	Type	Citation	Retractions
27458307	Derived	Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ipilimumab and Platinum/Etoposide	During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy

Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

All randomized participants who received at least one dose of blinded study therapy

Posted

Median

95% Confidence Interval

months

Randomization until date of death, up to March 2015, approximately 38 months

ID	Title	Description
OG000	Ipilimumab and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
OG001	Placebo and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Units	Counts
Participants	OG000478 OG001476

Title

Denominators

Categories

Title	Measurements
	OG00010.97(10.45 to 11.33) OG00110.94(10.02 to 11.50)

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		Log Rank		0.3775		Hazard Ratio (HR)	0.936			2-Sided	95	0.807	1.085			HR = ipilimumab over placebo		Superiority or Other (legacy)

Secondary

Overall Survival in All Randomized Participants

All randomized participants

Posted

Median

95% Confidence Interval

months

From randomization until date of death, up to March 2015, approximately 38 months

ID	Title	Description
OG000	Ipilimumab and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
OG001	Placebo and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Secondary

Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy

Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

All randomized participants who received at least one dose of blinded study therapy

Posted

Median

95% Confidence Interval

months

From randomization until disease progression, up to March 2015, approximately 38 months

ID	Title	Description
OG000	Ipilimumab and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
OG001	Placebo and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Autoimmune colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cardio-respiratory distress	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0013 affected561 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected562 at risk EG0015 affected561 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Condition aggravated	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0013 affected561 at risk
General physical condition abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG00036 affected562 at risk EG00143 affected561 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0014 affected561 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Pyomyositis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected562 at risk EG0013 affected561 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0017 affected561 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0012 affected561 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0015 affected561 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Death	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0013 affected561 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0010 affected561 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00042 affected562 at risk EG00113 affected561 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Embolic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Encephalitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Epilepsy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0011 affected561 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0013 affected561 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected562 at risk EG00113 affected561 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Mental disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Neuralgia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected562 at risk EG0014 affected561 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0010 affected561 at risk
Rectal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0013 affected561 at risk
Spinal cord disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Sudden cardiac death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Adrenalitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0011 affected561 at risk
Brain oedema	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0013 affected561 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0010 affected561 at risk
Circulatory collapse	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0012 affected561 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Enteritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Epididymitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Full blood count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0012 affected561 at risk
Hypophysitis	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0011 affected561 at risk
Infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0013 affected561 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Lipase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0018 affected561 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0016 affected561 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0010 affected561 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0013 affected561 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0009 affected562 at risk EG00113 affected561 at risk
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected562 at risk EG0019 affected561 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0013 affected561 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0010 affected561 at risk
Euthanasia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Food allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0012 affected561 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Monoplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00012 affected562 at risk EG0015 affected561 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0016 affected561 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Spinal cord compression	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Vertebral artery occlusion	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0011 affected561 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0012 affected561 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Central nervous system haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00024 affected562 at risk EG0011 affected561 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Disease progression	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected562 at risk EG0019 affected561 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00013 affected562 at risk EG00116 affected561 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0015 affected561 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0010 affected561 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hypothyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0010 affected561 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0013 affected561 at risk
Memory impairment	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Myasthenic syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Oral candidiasis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0014 affected561 at risk
Paraparesis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00033 affected562 at risk EG00116 affected561 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pyramidal tract syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected562 at risk EG00114 affected561 at risk
Right ventricular failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Tooth abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Vascular occlusion	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Acute psychosis	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0015 affected561 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0011 affected561 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Influenza like illness	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Myxoedema	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected562 at risk EG0013 affected561 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Tumour embolism	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0013 affected561 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cognitive disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0012 affected561 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0015 affected561 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00025 affected562 at risk EG00115 affected561 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Systematic Assessment	EG00013 affected562 at risk EG0015 affected561 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hypopituitarism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected562 at risk EG0017 affected561 at risk
Partial seizures	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected562 at risk EG0015 affected561 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0015 affected561 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0012 affected561 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00013 affected562 at risk EG00123 affected561 at risk
Ataxia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Atypical pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Blood sodium decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0015 affected561 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0014 affected561 at risk
Device related infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0012 affected561 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Dysarthria	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Glaucoma	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0011 affected561 at risk
Lobar pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0011 affected561 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0011 affected561 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0012 affected561 at risk
Mental status changes	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0012 affected561 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected562 at risk EG0011 affected561 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00015 affected562 at risk EG00120 affected561 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected562 at risk EG0010 affected561 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Paraplegia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Platelet count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected562 at risk EG0013 affected561 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0013 affected561 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0011 affected561 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected562 at risk EG0018 affected561 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected562 at risk EG0011 affected561 at risk
H1n1 influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Iiird nerve disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk
Viith nerve paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected562 at risk EG0010 affected561 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG00038 affected562 at risk EG00145 affected561 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00087 affected562 at risk EG00167 affected561 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00046 affected562 at risk EG00141 affected561 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00043 affected562 at risk EG00147 affected561 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00094 affected562 at risk EG00181 affected561 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG000169 affected562 at risk EG001138 affected561 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000159 affected562 at risk EG001116 affected561 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG000180 affected562 at risk EG001170 affected561 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00053 affected562 at risk EG00150 affected561 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG000121 affected562 at risk EG00128 affected561 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00030 affected562 at risk EG00124 affected561 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00038 affected562 at risk EG00132 affected561 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00047 affected562 at risk EG00131 affected561 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG00053 affected562 at risk EG00162 affected561 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000115 affected562 at risk EG00197 affected561 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG00047 affected562 at risk EG00126 affected561 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG00044 affected562 at risk EG00123 affected561 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00073 affected562 at risk EG00187 affected561 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000232 affected562 at risk EG001209 affected561 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG000199 affected562 at risk EG001208 affected561 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00037 affected562 at risk EG00126 affected561 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00075 affected562 at risk EG00183 affected561 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00067 affected562 at risk EG00156 affected561 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG00055 affected562 at risk EG00161 affected561 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00024 affected562 at risk EG00136 affected561 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000121 affected562 at risk EG00199 affected561 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG00038 affected562 at risk EG00127 affected561 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG00079 affected562 at risk EG00160 affected561 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00034 affected562 at risk EG00133 affected561 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG000171 affected562 at risk EG001189 affected561 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00052 affected562 at risk EG00159 affected561 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00026 affected562 at risk EG00132 affected561 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG000234 affected562 at risk EG001261 affected561 at risk
Platelet count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00039 affected562 at risk EG00148 affected561 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00082 affected562 at risk EG00115 affected561 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00064 affected562 at risk EG00184 affected561 at risk
White blood cell count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00051 affected562 at risk EG00151 affected561 at risk

ID	Title	Description
BG000	Ipilimumab and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
BG001	Placebo and Platinum/Etoposide	Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE				316	562	519	562
EG001	PLACEBO + PLATINUM/ETOPOSIDE				278	561	520	561

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes

ID	Term
D000074324	Ipilimumab
D005047	Etoposide
C061400	etoposide phosphate
D002945	Cisplatin
D016190	Carboplatin