Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subj... | NCT01285609

NCT01285609

ID	Type	Description	Link
2009-017396-19	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ipilimumab + Paclitaxel and Carboplatin	Experimental	Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses	Drug: Ipilimumab Drug: Paclitaxel Drug: Carboplatin
Placebo + Paclitaxel and Carboplatin	Placebo Comparator	Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses	Drug: Placebo Drug: Paclitaxel Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Ipilimumab	Drug		Ipilimumab + Paclitaxel and Carboplatin	BMS-734016
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in All Randomized Participants at Primary Endpoint	Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Sharp Memorial Hospital		San Diego	California	92123	United States
Va Connecticut Healthcare System

References Module

Label	URL
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ipilimumab With Paclitaxel/Carboplatin	Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Randomized Participants Who Received at Least One Dose of Blinded Study Therapy

Arm/Group Information

ID	Title	Description
BG000	Ipilimumab With Paclitaxel/Carboplatin	Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
BG001	Placebo With Paclitaxel/Carboplatin	Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.7± 8.27 BG00163.7± 8.70 BG00263.7± 8.47

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00152 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG Performance Status is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all pre-disease performance without restriction and (worst score) 5=death.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0	BG000135 BG001

Disease Stage at Study Entry

Non-Small Cell Lung Cancer is categorized in 4 Stages (I-IV). I: Cancer located only in lungs and has not spread to any lymph nodes. II: Cancer in the lung and nearby lymph nodes. III: Cancer in the lung and lymph nodes in the middle of the chest. Stage III has two subtypes, IIIA (cancer has spread only to lymph nodes on the same side of the chest where the cancer started) and IIIB (cancer has spread to the lymph nodes on the opposite side of the chest, or above the collar bone). IV: Cancer has spread to both lungs, to fluid in the area around the lungs, or to another part of the body.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Stage IV	BG000367 BG001

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 at Primary Endpoint

Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.

All treated participants who received at least one dose of blinded therapy

Posted

Median

95% Confidence Interval

months

Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)

ID	Title	Description
OG000	Ipilimumab With Paclitaxel/Carboplatin	Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
OG001	Placebo With Paclitaxel/Carboplatin	Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

Units	Counts
Participants	OG000388 OG001361

Title

Denominators

Categories

Title	Measurements
	OG00013.37(11.76 to 14.78) OG00112.42(11.60 to 13.63)

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	Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin	Log Rank	p-value based on an unstratified 2-sided log rank test	0.2517		Hazard Ratio (HR)	0.907			2-Sided	95	0.767	1.072			Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate		Superiority or Other (legacy)

Secondary

Overall Survival (OS) in All Randomized Participants at Primary Endpoint

All randomized participants

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Ipilimumab With Paclitaxel/Carboplatin	Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
OG001	Placebo With Paclitaxel/Carboplatin

Secondary

Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint

Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

All treated participants who received at least one dose of blinded therapy

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Ipilimumab With Paclitaxel/Carboplatin	Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses

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	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses	359	475	300	475	437	475
EG001	Placebo + Paclitaxel/ Carboplatin	Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses	371	473	235	473	428	473

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00021 affected475 at risk EG00110 affected473 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Autoimmune colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Blood pressure decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0018 affected473 at risk
Completed suicide	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0013 affected473 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Device related infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0013 affected473 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0014 affected473 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0015 affected473 at risk
Performance status decreased	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Spinal cord paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
White blood cell count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Asbestosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected475 at risk EG0017 affected473 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0005 affected475 at risk EG0010 affected473 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0014 affected473 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected475 at risk EG0012 affected473 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Device dislocation	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Embolism venous	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected475 at risk EG00110 affected473 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hemiparesis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Lobar pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG00035 affected475 at risk EG00137 affected473 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0013 affected473 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pupils unequal	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected475 at risk EG0018 affected473 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0013 affected473 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected475 at risk EG0012 affected473 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Disease progression	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0015 affected473 at risk
Fulminant type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hypophysitis	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0015 affected473 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Peripheral embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected475 at risk EG00110 affected473 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0013 affected473 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected475 at risk EG00111 affected473 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Viraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0013 affected473 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Brain oedema	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Death	General disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected475 at risk EG0017 affected473 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Empyema	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Extravasation	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected475 at risk EG00110 affected473 at risk
Heart injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0014 affected473 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Partial seizures	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pericarditis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
Platelet count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0013 affected473 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0011 affected473 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG00021 affected475 at risk EG00114 affected473 at risk
Red blood cell count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0012 affected473 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected475 at risk EG0015 affected473 at risk
Abdominal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Body temperature increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Circulatory collapse	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected475 at risk EG0017 affected473 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00017 affected475 at risk EG00116 affected473 at risk
Embolism	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Endocarditis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Febrile infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hydrocephalus	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Hypopituitarism	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0013 affected473 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Localised infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0012 affected473 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Lung abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 affected475 at risk EG0015 affected473 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0018 affected473 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Orchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Perivascular dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Thyroiditis	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Brain injury	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0013 affected473 at risk
Delirium	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Depressed mood	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Hypersomnia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Laryngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Liver function test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Nephropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0010 affected473 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pneumococcal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00037 affected475 at risk EG00134 affected473 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected475 at risk EG0014 affected473 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected475 at risk EG0010 affected473 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected475 at risk EG0014 affected473 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Azotaemia	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0013 affected473 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
C-reactive protein increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0012 affected473 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Device occlusion	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00037 affected475 at risk EG00110 affected473 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected475 at risk EG0017 affected473 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Herpes zoster	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0012 affected473 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Hypothalamo-pituitary disorder	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0016 affected473 at risk
Renal function test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected475 at risk EG0017 affected473 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Superior vena cava occlusion	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Tracheobronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0012 affected473 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0012 affected473 at risk
Blood glucose increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0014 affected473 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Endocrine disorder	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Facial paresis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00020 affected475 at risk EG00111 affected473 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0012 affected473 at risk
General physical condition abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0013 affected473 at risk
Infectious colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected475 at risk EG0011 affected473 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0011 affected473 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00016 affected475 at risk EG0019 affected473 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected475 at risk EG0010 affected473 at risk
Phlebitis superficial	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Polyneuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Pulmonary artery stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Renal colic	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0012 affected473 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0011 affected473 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Tuberculosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected475 at risk EG0011 affected473 at risk
Ulcerative keratitis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected475 at risk EG0010 affected473 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG000171 affected475 at risk EG001157 affected473 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG000145 affected475 at risk EG001116 affected473 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00038 affected475 at risk EG00130 affected473 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00066 affected475 at risk EG00161 affected473 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG00025 affected475 at risk EG00131 affected473 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00071 affected475 at risk EG00198 affected473 at risk
White blood cell count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00025 affected475 at risk EG00131 affected473 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG00034 affected475 at risk EG00120 affected473 at risk
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG00080 affected475 at risk EG00155 affected473 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00032 affected475 at risk EG00126 affected473 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG00026 affected475 at risk EG00145 affected473 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00020 affected475 at risk EG00128 affected473 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00044 affected475 at risk EG00127 affected473 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00030 affected475 at risk EG00122 affected473 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00044 affected475 at risk EG00154 affected473 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00077 affected475 at risk EG00170 affected473 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG000181 affected475 at risk EG001175 affected473 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00034 affected475 at risk EG00141 affected473 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00027 affected475 at risk EG00115 affected473 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG00061 affected475 at risk EG00149 affected473 at risk
Mucosal inflammation	General disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected475 at risk EG00127 affected473 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00020 affected475 at risk EG00124 affected473 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00061 affected475 at risk EG00157 affected473 at risk
Platelet count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00047 affected475 at risk EG00132 affected473 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG00091 affected475 at risk EG00170 affected473 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00089 affected475 at risk EG00168 affected473 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00024 affected475 at risk EG00123 affected473 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG00037 affected475 at risk EG00126 affected473 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00024 affected475 at risk EG0017 affected473 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00035 affected475 at risk EG00158 affected473 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00094 affected475 at risk EG00197 affected473 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00037 affected475 at risk EG00111 affected473 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00078 affected475 at risk EG00127 affected473 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00077 affected475 at risk EG00158 affected473 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00082 affected475 at risk EG00185 affected473 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00051 affected475 at risk EG00131 affected473 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG00087 affected475 at risk EG00145 affected473 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00034 affected475 at risk EG00138 affected473 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000117 affected475 at risk EG001103 affected473 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000145 affected475 at risk EG00189 affected473 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG000142 affected475 at risk EG001140 affected473 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00025 affected475 at risk EG00126 affected473 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG000152 affected475 at risk EG001151 affected473 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG000107 affected475 at risk EG001102 affected473 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG00031 affected475 at risk EG00131 affected473 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00043 affected475 at risk EG00143 affected473 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00027 affected475 at risk EG00124 affected473 at risk

ID	Term
D000074324	Ipilimumab
D017239	Paclitaxel
D016190	Carboplatin

Ancestor Terms

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
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes