Study of Nivolumab (BMS-936558) Compared With Dacarbazine... | NCT01721772

ID	Type	Description	Link
2012-003718-16	EudraCT Number

Label	Type	Description	Intervention Names
Nivolumab, 3 mg/kg	Experimental	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.	Biological: BMS-936558 (Nivolumab) Drug: Placebo matching Dacarbazine
Dacarbazine, 1000 mg/m^2	Active Comparator	Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.	Biological: Placebo matching BMS-936558 (Nivolumab) Drug: Dacarbazine

Name	Type	Description	Arm Group Labels	Other Names
BMS-936558 (Nivolumab)	Biological		Nivolumab, 3 mg/kg
Placebo matching BMS-936558 (Nivolumab)

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.	From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
Overall Survival (OS) Rate	OS rate is calculated as the percentage of participants alive at the indicated timepoints	From randomization to 6 months and or to 12 months

Measure	Description	Time Frame
Progression-free Survival (PFS)	Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.

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

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion Cidea		Buenos Aires	Distrito Federal	1121	Argentina
Instituto Medico Especialazado Alexander Fleming

PubMed Identifier	Type	Citation	Retractions
39504507	Derived	Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
32997575

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
FG001

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)

OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Units	Counts
Participants	OG000210 OG001208

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA due to insufficient number of events OG00110.84(9.33 to 12.09)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Stratified Log Rank Test		<0.0001		Hazard Ratio (HR)	0.42			2-Sided	95	0.30	0.60					Superiority or Other (legacy)

Secondary

Progression-free Survival (PFS)

Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization up to date of disease progression or death, up to approximately 84 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Secondary

Progression-free Survival (PFS) Rate

The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to the specified timepoints, up to 84 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Units	Counts
Participants

Secondary

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

Secondary

Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level

Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of disease progression or death, up to approximately 94 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Primary

Overall Survival (OS) Rate

OS rate is calculated as the percentage of participants alive at the indicated timepoints

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to 6 months and or to 12 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Units	Counts
Participants

Secondary

Change From Baseline in Health-related Quality of Life (HRQoL) Scores

HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.

All randomized participants with available measurements

Posted

Mean

Standard Deviation

Units on a scale

At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Post-Hoc

Overall Survival (OS) Extended

OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 94 months.

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Post-Hoc

Overall Survival (OS) Rate Extended

OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization to the specified timepoints, up to 84 months

ID	Title	Description
OG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
OG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Lymphadenopathy	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected205 at risk
Pancytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0014 affected205 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0014 affected205 at risk
Angina pectoris	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Atrial fibrillation	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Atrial flutter	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cardiac failure	Cardiac disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Tachycardia	Cardiac disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Deafness unilateral	Ear and labyrinth disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Vertigo	Ear and labyrinth disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypophysitis	Endocrine disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Hypopituitarism	Endocrine disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Diplopia	Eye disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Eyelid retraction	Eye disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Retinal vein thrombosis	Eye disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Uveitis	Eye disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Visual acuity reduced	Eye disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected205 at risk
Abdominal distension	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0014 affected205 at risk
Ascites	Gastrointestinal disorders	24.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected205 at risk
Colitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0004 affected206 at risk EG0011 affected205 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG0006 affected206 at risk EG0014 affected205 at risk
Enterocolitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected205 at risk
Gastric haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Gastric mucosal lesion	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Gastric ulcer	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Gastrointestinal disorder	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Intestinal obstruction	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Pancreatitis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0012 affected205 at risk
Chills	General disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Death	General disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0013 affected205 at risk
General physical health deterioration	General disorders	24.0	Systematic Assessment	EG0006 affected206 at risk EG0016 affected205 at risk
Infusion site reaction	General disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Injection site reaction	General disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Multiple organ dysfunction syndrome	General disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Non-cardiac chest pain	General disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Pain	General disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0016 affected205 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG0004 affected206 at risk EG0012 affected205 at risk
Cholecystitis acute	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cholecystitis chronic	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cholelithiasis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hepatic function abnormal	Hepatobiliary disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Hepatitis	Hepatobiliary disorders	24.0	Systematic Assessment	EG0003 affected206 at risk EG0010 affected205 at risk
Jaundice	Hepatobiliary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypersensitivity	Immune system disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cellulitis	Infections and infestations	24.0	Systematic Assessment	EG0003 affected206 at risk EG0012 affected205 at risk
Coronavirus infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Device related sepsis	Infections and infestations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Erysipelas	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Infected cyst	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Infusion site infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Klebsiella infection	Infections and infestations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Lower respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Pneumonia	Infections and infestations	24.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected205 at risk
Pyelonephritis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Sepsis	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Skin infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Arthropod sting	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Hip fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Infusion related reaction	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Post procedural complication	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Radiation skin injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Spinal column injury	Injury, poisoning and procedural complications	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Blood calcium decreased	Investigations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
General physical condition abnormal	Investigations	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Oxygen saturation decreased	Investigations	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Pancreatic enzymes abnormal	Investigations	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Dehydration	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypercalcaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected205 at risk
Hyponatraemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0012 affected205 at risk
Bone pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0008 affected206 at risk EG0010 affected205 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Gastrointestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected206 at risk EG0011 affected205 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG00032 affected206 at risk EG00169 affected205 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0003 affected206 at risk EG0011 affected205 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0002 affected206 at risk EG0013 affected205 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Nodular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Cerebral haemorrhage	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Cerebrovascular accident	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Cognitive disorder	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Disturbance in attention	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Epilepsy	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Facial paresis	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Guillain-Barre syndrome	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Ischaemic stroke	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Nerve compression	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Neurological decompensation	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Presyncope	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Seizure	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0012 affected205 at risk
Somnolence	Nervous system disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Spinal cord compression	Nervous system disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0012 affected205 at risk
Subarachnoid haemorrhage	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Transient ischaemic attack	Nervous system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Device dislocation	Product Issues	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Device occlusion	Product Issues	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Confusional state	Psychiatric disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0014 affected205 at risk
Disorientation	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Mania	Psychiatric disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Psychotic disorder	Psychiatric disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Acute kidney injury	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0012 affected205 at risk
Haematuria	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Nephrolithiasis	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Renal failure	Renal and urinary disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Renal injury	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Ureterolithiasis	Renal and urinary disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Endometriosis	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Genital haemorrhage	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Ovarian cyst	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0004 affected206 at risk EG0010 affected205 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0017 affected205 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0017 affected205 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0012 affected205 at risk
Rash	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG0010 affected205 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Rash papular	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Sarcoid-like reaction	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Skin lesion	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk
Embolism	Vascular disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Haematoma	Vascular disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Haemorrhage	Vascular disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0010 affected205 at risk
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Pelvic venous thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0000 affected206 at risk EG0011 affected205 at risk
Thrombosis	Vascular disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG0011 affected205 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG00026 affected206 at risk EG00124 affected205 at risk
Neutropenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0001 affected206 at risk EG00126 affected205 at risk
Thrombocytopenia	Blood and lymphatic system disorders	24.0	Systematic Assessment	EG0002 affected206 at risk EG00122 affected205 at risk
Hyperthyroidism	Endocrine disorders	24.0	Systematic Assessment	EG00011 affected206 at risk EG0013 affected205 at risk
Hypothyroidism	Endocrine disorders	24.0	Systematic Assessment	EG00020 affected206 at risk EG0018 affected205 at risk
Abdominal pain	Gastrointestinal disorders	24.0	Systematic Assessment	EG00030 affected206 at risk EG00121 affected205 at risk
Abdominal pain upper	Gastrointestinal disorders	24.0	Systematic Assessment	EG00017 affected206 at risk EG00112 affected205 at risk
Constipation	Gastrointestinal disorders	24.0	Systematic Assessment	EG00057 affected206 at risk EG00157 affected205 at risk
Diarrhoea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00075 affected206 at risk EG00158 affected205 at risk
Dyspepsia	Gastrointestinal disorders	24.0	Systematic Assessment	EG00011 affected206 at risk EG0017 affected205 at risk
Nausea	Gastrointestinal disorders	24.0	Systematic Assessment	EG00059 affected206 at risk EG001104 affected205 at risk
Vomiting	Gastrointestinal disorders	24.0	Systematic Assessment	EG00034 affected206 at risk EG00154 affected205 at risk
Asthenia	General disorders	24.0	Systematic Assessment	EG00043 affected206 at risk EG00138 affected205 at risk
Fatigue	General disorders	24.0	Systematic Assessment	EG00077 affected206 at risk EG00160 affected205 at risk
Influenza like illness	General disorders	24.0	Systematic Assessment	EG00013 affected206 at risk EG0014 affected205 at risk
Oedema peripheral	General disorders	24.0	Systematic Assessment	EG00026 affected206 at risk EG00111 affected205 at risk
Pain	General disorders	24.0	Systematic Assessment	EG00013 affected206 at risk EG00113 affected205 at risk
Pyrexia	General disorders	24.0	Systematic Assessment	EG00036 affected206 at risk EG00129 affected205 at risk
Bronchitis	Infections and infestations	24.0	Systematic Assessment	EG00012 affected206 at risk EG0014 affected205 at risk
Influenza	Infections and infestations	24.0	Systematic Assessment	EG00015 affected206 at risk EG0013 affected205 at risk
Nasopharyngitis	Infections and infestations	24.0	Systematic Assessment	EG00034 affected206 at risk EG00110 affected205 at risk
Rhinitis	Infections and infestations	24.0	Systematic Assessment	EG00012 affected206 at risk EG0013 affected205 at risk
Upper respiratory tract infection	Infections and infestations	24.0	Systematic Assessment	EG00020 affected206 at risk EG00113 affected205 at risk
Urinary tract infection	Infections and infestations	24.0	Systematic Assessment	EG00013 affected206 at risk EG00111 affected205 at risk
Alanine aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00017 affected206 at risk EG0017 affected205 at risk
Aspartate aminotransferase increased	Investigations	24.0	Systematic Assessment	EG00012 affected206 at risk EG0018 affected205 at risk
Blood alkaline phosphatase increased	Investigations	24.0	Systematic Assessment	EG00012 affected206 at risk EG0017 affected205 at risk
Blood creatinine increased	Investigations	24.0	Systematic Assessment	EG00012 affected206 at risk EG0016 affected205 at risk
Gamma-glutamyltransferase increased	Investigations	24.0	Systematic Assessment	EG00013 affected206 at risk EG0016 affected205 at risk
Platelet count decreased	Investigations	24.0	Systematic Assessment	EG0000 affected206 at risk EG00111 affected205 at risk
Decreased appetite	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00040 affected206 at risk EG00137 affected205 at risk
Hyperglycaemia	Metabolism and nutrition disorders	24.0	Systematic Assessment	EG00014 affected206 at risk EG0010 affected205 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00046 affected206 at risk EG00129 affected205 at risk
Back pain	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00039 affected206 at risk EG00123 affected205 at risk
Myalgia	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00018 affected206 at risk EG00113 affected205 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	24.0	Systematic Assessment	EG00034 affected206 at risk EG00120 affected205 at risk
Dizziness	Nervous system disorders	24.0	Systematic Assessment	EG00014 affected206 at risk EG00115 affected205 at risk
Headache	Nervous system disorders	24.0	Systematic Assessment	EG00045 affected206 at risk EG00132 affected205 at risk
Anxiety	Psychiatric disorders	24.0	Systematic Assessment	EG00016 affected206 at risk EG00112 affected205 at risk
Insomnia	Psychiatric disorders	24.0	Systematic Assessment	EG00015 affected206 at risk EG0019 affected205 at risk
Cough	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00040 affected206 at risk EG00129 affected205 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00025 affected206 at risk EG00125 affected205 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	24.0	Systematic Assessment	EG00011 affected206 at risk EG0014 affected205 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00014 affected206 at risk EG0011 affected205 at risk
Dry skin	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00021 affected206 at risk EG0015 affected205 at risk
Erythema	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00029 affected206 at risk EG0017 affected205 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG0005 affected206 at risk EG00112 affected205 at risk
Pruritus	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00064 affected206 at risk EG00140 affected205 at risk
Rash	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00063 affected206 at risk EG00129 affected205 at risk
Vitiligo	Skin and subcutaneous tissue disorders	24.0	Systematic Assessment	EG00037 affected206 at risk EG0013 affected205 at risk
Hypertension	Vascular disorders	24.0	Systematic Assessment	EG00022 affected206 at risk EG0015 affected205 at risk
Hypotension	Vascular disorders	24.0	Systematic Assessment	EG0005 affected206 at risk EG00111 affected205 at risk

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

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

ID	Title	Description
BG000	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
BG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
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	Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine	Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion	126	210	125	206	191	206
EG001	Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab	Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion	165	208	119	205	187	205