A Study to Compare BMS-936558 to the Physician's Choice o... | NCT01721746

NCT01721746

ID	Type	Description	Link
2012-001828-35	EudraCT Number

Status Module

Oversight 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
BMS-936558 3 mg/kg (IV)	Experimental	BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Biological: BMS-936558
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Active Comparator	Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends	Drug: Dacarbazine Drug: Carboplatin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
BMS-936558	Biological		BMS-936558 3 mg/kg (IV)
Dacarbazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1	From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Overall Survival (OS)	Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.	Up to 96 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Phoenix	Arizona	85054	United States
UCSD Moores Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28671856	Derived	Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.
25795410

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
FG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
BG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W
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
	BG00058.7± 14.1 BG00160.3± 12.4 BG00259.2± 13.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00096 BG00148 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0011 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000269 BG001129 BG002

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

Objective Response Rate (ORR)

Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1

All randomized participants

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W

Units	Counts
Participants	OG000272 OG001133

Title

Denominators

Categories

Title	Measurements
	OG00027.2(22.0 to 32.9) OG0019.8(5.3 to 16.1)

Primary

Overall Survival (OS)

Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.

All randomized participants

Posted

Median

95% Confidence Interval

Months

Up to 96 months

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.

All randomized participants

Posted

Median

95% Confidence Interval

months

From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

Units	Counts
Participants

Secondary

Objective Response Rate (ORR) by Baseline PD-L1 Expression

Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.

All PD-L1 Evaluable Participants for ORR

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) by PD-L1 Positive

Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

All PD-L1 positive evaluable participants for OS

Posted

Median

95% Confidence Interval

Months

Up to 96 months

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) by PD-L1 Negative

All PD-L1 negative evaluable participants for OS

Posted

Median

95% Confidence Interval

Months

Up to 96 months

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

Units	Counts
Participants	OG000

Secondary

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

Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.

Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.

A 10 point difference on a 100 point scale between treatments was considered clinically significant.

All randomized participants

Posted

Mean

Standard Deviation

Units on a scale

From Baseline (Day1) to second Follow-Up (Up to 96 months)

ID	Title	Description
OG000	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W
OG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W

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	Nivolumab	Nivolumab 3 mg/kg IV over 60 minutes Q2W	206	268	191	268	255	268
EG001	Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)	Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W	88	102	37	102	95	102

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0012 affected102 at risk
Blood loss anaemia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Febrile neutropenia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0012 affected102 at risk
Lymphadenopathy	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Splenic haematoma	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Splenic lesion	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Thrombocytopenia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Acute myocardial infarction	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Atrial fibrillation	Cardiac disorders	23.1	Systematic Assessment	EG0004 affected268 at risk EG0010 affected102 at risk
Atrial flutter	Cardiac disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Cardiac arrest	Cardiac disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Cardiac failure	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Cardio-respiratory arrest	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Myocardial infarction	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Pericarditis	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Sinus tachycardia	Cardiac disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Ventricular arrhythmia	Cardiac disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Adrenal haemorrhage	Endocrine disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Adrenal insufficiency	Endocrine disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Hypothyroidism	Endocrine disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Retinal detachment	Eye disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Abdominal pain	Gastrointestinal disorders	23.1	Systematic Assessment	EG0005 affected268 at risk EG0011 affected102 at risk
Abdominal pain upper	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Ascites	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Colitis	Gastrointestinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0011 affected102 at risk
Constipation	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Diarrhoea	Gastrointestinal disorders	23.1	Systematic Assessment	EG0004 affected268 at risk EG0012 affected102 at risk
Diverticular perforation	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Dysphagia	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Food poisoning	Gastrointestinal disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Haematemesis	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Inguinal hernia	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Intestinal fistula	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Nausea	Gastrointestinal disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0011 affected102 at risk
Pancreatitis	Gastrointestinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Small intestinal obstruction	Gastrointestinal disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Small intestinal perforation	Gastrointestinal disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Vomiting	Gastrointestinal disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0013 affected102 at risk
Asthenia	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Chest pain	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Fatigue	General disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0012 affected102 at risk
Gait disturbance	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
General physical health deterioration	General disorders	23.1	Systematic Assessment	EG0006 affected268 at risk EG0010 affected102 at risk
Infusion site extravasation	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Multiple organ dysfunction syndrome	General disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Non-cardiac chest pain	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Pain	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0012 affected102 at risk
Pelvic mass	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Pyrexia	General disorders	23.1	Systematic Assessment	EG0005 affected268 at risk EG0012 affected102 at risk
Ulcer	General disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Biliary obstruction	Hepatobiliary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hepatic haemorrhage	Hepatobiliary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hepatitis	Hepatobiliary disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Hepatocellular injury	Hepatobiliary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Jaundice cholestatic	Hepatobiliary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hypersensitivity	Immune system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Bacterial infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Bronchitis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Bronchitis bacterial	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Cellulitis	Infections and infestations	23.1	Systematic Assessment	EG0002 affected268 at risk EG0011 affected102 at risk
Clostridium difficile colitis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Clostridium difficile infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Cystitis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Device related infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Diverticulitis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Erysipelas	Infections and infestations	23.1	Systematic Assessment	EG0002 affected268 at risk EG0011 affected102 at risk
Febrile infection	Infections and infestations	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Gastroenteritis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Herpes zoster	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Localised infection	Infections and infestations	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Lower respiratory tract infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Neutropenic sepsis	Infections and infestations	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Pneumonia	Infections and infestations	23.1	Systematic Assessment	EG0008 affected268 at risk EG0010 affected102 at risk
Pneumonia pseudomonal	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Sepsis	Infections and infestations	23.1	Systematic Assessment	EG0004 affected268 at risk EG0010 affected102 at risk
Urinary tract infection	Infections and infestations	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Urosepsis	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Vascular device infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Wound infection	Infections and infestations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Femur fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0002 affected268 at risk EG0011 affected102 at risk
Hip fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Humerus fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Infusion related reaction	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Open fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Postoperative ileus	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Radiation necrosis	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Rib fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Spinal fracture	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Subdural haematoma	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Vascular access site thrombosis	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Wound dehiscence	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Alanine aminotransferase increased	Investigations	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Aspartate aminotransferase increased	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Blood alkaline phosphatase increased	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Ejection fraction abnormal	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
General physical condition abnormal	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hepatic enzyme increased	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Influenza B virus test positive	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Lipase increased	Investigations	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Liver function test abnormal	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Liver function test increased	Investigations	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Dehydration	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0005 affected268 at risk EG0010 affected102 at risk
Diabetes mellitus	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Failure to thrive	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hypercalcaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hyperglycaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hypoglycaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Hypokalaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hyponatraemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Arthritis	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0007 affected268 at risk EG0012 affected102 at risk
Flank pain	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0004 affected268 at risk EG0010 affected102 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0003 affected268 at risk EG0011 affected102 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0005 affected268 at risk EG0011 affected102 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG00086 affected268 at risk EG00118 affected102 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0011 affected102 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0008 affected268 at risk EG0010 affected102 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Skin neoplasm bleeding	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0004 affected268 at risk EG0010 affected102 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Tumour fistulisation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Aphasia	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Autoimmune neuropathy	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Brain oedema	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Cerebrovascular accident	Nervous system disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0011 affected102 at risk
Demyelination	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Dizziness	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Epilepsy	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Facial paresis	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Haemorrhage intracranial	Nervous system disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Headache	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Incoherent	Nervous system disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Monoplegia	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Paraplegia	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Post herpetic neuralgia	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Seizure	Nervous system disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Status epilepticus	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Transient ischaemic attack	Nervous system disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
VIth nerve paralysis	Nervous system disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Burnout syndrome	Psychiatric disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Confusional state	Psychiatric disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0010 affected102 at risk
Acute kidney injury	Renal and urinary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0012 affected102 at risk
Hydronephrosis	Renal and urinary disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Nephrolithiasis	Renal and urinary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Renal failure	Renal and urinary disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Renal impairment	Renal and urinary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0005 affected268 at risk EG0013 affected102 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0012 affected102 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Rash	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Deep vein thrombosis	Vascular disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Embolism	Vascular disorders	23.1	Systematic Assessment	EG0002 affected268 at risk EG0010 affected102 at risk
Hypertension	Vascular disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Hypotension	Vascular disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG0011 affected102 at risk
Peripheral embolism	Vascular disorders	23.1	Systematic Assessment	EG0000 affected268 at risk EG0011 affected102 at risk
Peripheral ischaemia	Vascular disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk
Superior vena cava syndrome	Vascular disorders	23.1	Systematic Assessment	EG0001 affected268 at risk EG0010 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG00065 affected268 at risk EG00131 affected102 at risk
Leukopenia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0004 affected268 at risk EG00110 affected102 at risk
Neutropenia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0003 affected268 at risk EG00124 affected102 at risk
Thrombocytopenia	Blood and lymphatic system disorders	23.1	Systematic Assessment	EG0008 affected268 at risk EG00111 affected102 at risk
Hypothyroidism	Endocrine disorders	23.1	Systematic Assessment	EG00027 affected268 at risk EG0010 affected102 at risk
Abdominal pain	Gastrointestinal disorders	23.1	Systematic Assessment	EG00050 affected268 at risk EG00113 affected102 at risk
Abdominal pain upper	Gastrointestinal disorders	23.1	Systematic Assessment	EG00021 affected268 at risk EG0016 affected102 at risk
Constipation	Gastrointestinal disorders	23.1	Systematic Assessment	EG00053 affected268 at risk EG00123 affected102 at risk
Diarrhoea	Gastrointestinal disorders	23.1	Systematic Assessment	EG00090 affected268 at risk EG00118 affected102 at risk
Dry mouth	Gastrointestinal disorders	23.1	Systematic Assessment	EG00014 affected268 at risk EG0013 affected102 at risk
Dyspepsia	Gastrointestinal disorders	23.1	Systematic Assessment	EG00021 affected268 at risk EG0014 affected102 at risk
Nausea	Gastrointestinal disorders	23.1	Systematic Assessment	EG00091 affected268 at risk EG00143 affected102 at risk
Vomiting	Gastrointestinal disorders	23.1	Systematic Assessment	EG00057 affected268 at risk EG00124 affected102 at risk
Asthenia	General disorders	23.1	Systematic Assessment	EG00035 affected268 at risk EG00111 affected102 at risk
Chills	General disorders	23.1	Systematic Assessment	EG00018 affected268 at risk EG0013 affected102 at risk
Fatigue	General disorders	23.1	Systematic Assessment	EG000135 affected268 at risk EG00152 affected102 at risk
Influenza like illness	General disorders	23.1	Systematic Assessment	EG00020 affected268 at risk EG0014 affected102 at risk
Oedema peripheral	General disorders	23.1	Systematic Assessment	EG00044 affected268 at risk EG0015 affected102 at risk
Pain	General disorders	23.1	Systematic Assessment	EG00027 affected268 at risk EG0014 affected102 at risk
Pyrexia	General disorders	23.1	Systematic Assessment	EG00052 affected268 at risk EG00110 affected102 at risk
Nasopharyngitis	Infections and infestations	23.1	Systematic Assessment	EG00026 affected268 at risk EG0014 affected102 at risk
Upper respiratory tract infection	Infections and infestations	23.1	Systematic Assessment	EG00025 affected268 at risk EG0012 affected102 at risk
Urinary tract infection	Infections and infestations	23.1	Systematic Assessment	EG00024 affected268 at risk EG0014 affected102 at risk
Infusion related reaction	Injury, poisoning and procedural complications	23.1	Systematic Assessment	EG0003 affected268 at risk EG0019 affected102 at risk
Alanine aminotransferase increased	Investigations	23.1	Systematic Assessment	EG00029 affected268 at risk EG0014 affected102 at risk
Aspartate aminotransferase increased	Investigations	23.1	Systematic Assessment	EG00038 affected268 at risk EG0016 affected102 at risk
Blood alkaline phosphatase increased	Investigations	23.1	Systematic Assessment	EG00022 affected268 at risk EG0013 affected102 at risk
Blood creatinine increased	Investigations	23.1	Systematic Assessment	EG00020 affected268 at risk EG0012 affected102 at risk
Neutrophil count decreased	Investigations	23.1	Systematic Assessment	EG0001 affected268 at risk EG0018 affected102 at risk
Platelet count decreased	Investigations	23.1	Systematic Assessment	EG00011 affected268 at risk EG0019 affected102 at risk
Weight decreased	Investigations	23.1	Systematic Assessment	EG00025 affected268 at risk EG0018 affected102 at risk
White blood cell count decreased	Investigations	23.1	Systematic Assessment	EG0007 affected268 at risk EG0019 affected102 at risk
Decreased appetite	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00054 affected268 at risk EG00121 affected102 at risk
Hyperglycaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00014 affected268 at risk EG0011 affected102 at risk
Hyperkalaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00014 affected268 at risk EG0013 affected102 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00020 affected268 at risk EG0011 affected102 at risk
Hypocalcaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00015 affected268 at risk EG0010 affected102 at risk
Hypokalaemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00015 affected268 at risk EG0011 affected102 at risk
Hyponatraemia	Metabolism and nutrition disorders	23.1	Systematic Assessment	EG00025 affected268 at risk EG0012 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00076 affected268 at risk EG00121 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00055 affected268 at risk EG0011 affected102 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00016 affected268 at risk EG0011 affected102 at risk
Myalgia	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00031 affected268 at risk EG00110 affected102 at risk
Neck pain	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00015 affected268 at risk EG0013 affected102 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	23.1	Systematic Assessment	EG00037 affected268 at risk EG00113 affected102 at risk
Dizziness	Nervous system disorders	23.1	Systematic Assessment	EG00030 affected268 at risk EG0015 affected102 at risk
Headache	Nervous system disorders	23.1	Systematic Assessment	EG00047 affected268 at risk EG00111 affected102 at risk
Neuropathy peripheral	Nervous system disorders	23.1	Systematic Assessment	EG00010 affected268 at risk EG00111 affected102 at risk
Paraesthesia	Nervous system disorders	23.1	Systematic Assessment	EG00013 affected268 at risk EG00113 affected102 at risk
Anxiety	Psychiatric disorders	23.1	Systematic Assessment	EG00019 affected268 at risk EG0011 affected102 at risk
Depression	Psychiatric disorders	23.1	Systematic Assessment	EG0008 affected268 at risk EG0016 affected102 at risk
Insomnia	Psychiatric disorders	23.1	Systematic Assessment	EG00034 affected268 at risk EG0016 affected102 at risk
Cough	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG00073 affected268 at risk EG0018 affected102 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	23.1	Systematic Assessment	EG00052 affected268 at risk EG00114 affected102 at risk
Alopecia	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG0008 affected268 at risk EG00130 affected102 at risk
Dry skin	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG00024 affected268 at risk EG0013 affected102 at risk
Pruritus	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG00073 affected268 at risk EG0012 affected102 at risk
Rash	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG00057 affected268 at risk EG0016 affected102 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG00022 affected268 at risk EG0012 affected102 at risk
Vitiligo	Skin and subcutaneous tissue disorders	23.1	Systematic Assessment	EG00031 affected268 at risk EG0011 affected102 at risk
Hypertension	Vascular disorders	23.1	Systematic Assessment	EG00021 affected268 at risk EG0014 affected102 at risk

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
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D056831	Coordination Complexes
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

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
D000077594	Nivolumab
D003606	Dacarbazine
D016190	Carboplatin
D017239	Paclitaxel