Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India (NCT NCT04513522)

Last Updated: 2025-07-11

Results Overview

IMAEs are a type of adverse event that occurs when the immune system reacts against the body's own tissues, including diarrhea/colitis, hepatitis, pneumonitis, nephritis and renal dysfunction, rash, and endocrine (adrenal insufficiency, hypophysitis, hypothyroidism/thyroiditis, hyperthyroidism, and diabetes mellitus). IMAE analyses includes events, regardless of causality, which occurred during the study and follow-up. Only participants who received immune-modulating medication for treatment of the event are reported, with the exception of endocrine events, which will be included regardless of treatment since these events are often managed without immunosuppression. High grade (Grade 3 to 4 and Grade 5) IMAEs are reported. IMAEs are graded on a scale from 1 to 5, in which Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events may require hospitalization; Grade 5 events are fatal.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

From first dose until 100 days after the last dose or for a maximum of 52 weeks from the date of the first on-study dose of nivolumab, whichever occurs earlier.

Results posted on

2025-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab + Ipilimumab Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Overall Study STARTED	101
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab + Ipilimumab Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Overall Study Other reasons	1
Overall Study Adverse event unrelated to study drug	9
Overall Study Study drug toxicity	14
Overall Study Disease progression	39
Overall Study Participants withdrew consent	2

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Nivolumab With Ipilimumab in Participants With Untreated Advanced Kidney Cancer Conducted in India

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab + Ipilimumab n=101 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Age, Continuous	56.0 Years STANDARD_DEVIATION 9.99 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose until 100 days after the last dose or for a maximum of 52 weeks from the date of the first on-study dose of nivolumab, whichever occurs earlier.

Population: All treated participants

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=101 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Pneumonitis Grade 3-4	2 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Nephritis and Renal Dysfunction Grade 3-4	1 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Rash Grade 3-4	2 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Adrenal Insufficiency Grade 3-4	1 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Diarrhea/Colitis Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Hepatitis Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Nephritis and Renal Dysfunction Grade 5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Rash Grade 5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Hypersensitivity Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Adrenal Insufficiency Grade 5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Hypothyroidism/Thyroiditis Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Diabetes Mellitus Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Hyperthyroidism Grade 3-5	0 Participants
Total Number of Participants Experiencing High Grade Immune-Mediated Adverse Events (IMAE) Hypophysitis Grade 3-5	0 Participants

SECONDARY outcome

Timeframe: From first dose until onset of IMAE (up to approximately 15 months)

Population: All treated participants who experienced at least 1 IMAE

Time to onset is defined as the time between the day of the first dose of study treatment and the onset date of the earliest AE (Grades 3-5) in this category. All IMAEs that occurred between first dose and 100 days past last dose are recorded. IMAEs are a type of adverse event that occurs when the immune system reacts against the body's own tissues. IMAE analyses includes events, regardless of causality, which occurred during the study and follow-up. Only participants who received immune-modulating medication for treatment of the event are reported, with the exception of endocrine events, which will be included regardless of treatment since these events are often managed without immunosuppression. High grade (Grades 3 through 5) IMAEs are reported. IMAEs are graded on a scale from 1 to 5, in which Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events may require hospitalization; Grade 5 events are fatal.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=11 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE) ADRENAL INSUFFICIENCY	9.9 Weeks Interval 9.9 to 9.9
Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE) PNEUMONITIS	7.29 Weeks Interval 1.4 to 13.1
Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE) NEPHRITIS AND RENAL DYSFUNCTION	20.00 Weeks Interval 20.0 to 20.0
Time to Onset of High Grade Immune-Mediated Adverse Event (IMAE) RASH	29.21 Weeks Interval 29.0 to 29.4

SECONDARY outcome

Timeframe: From first dose until resolution of IMAE (up to approximately 15 months)

Population: All treated participants who experienced at least 1 IMAE that was resolved. Participants who experienced an IMAE that did not resolve were censored.

Time to resolution of IMAEs is defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered AEs experienced by the participant in this category per adverse event criteria category. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known alive date. Improvement to the grade at baseline implies that all different events in the clustered adverse event should at least have improved to the corresponding (i.e. with same preferred term) baseline grade. High grade (Grades 3 through 5) IMAEs are reported. IMAEs are graded on a scale from 1 to 5, in which Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events may require hospitalization; Grade 5 events are fatal.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=9 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Time to Resolution of High Grade Immune-Mediated Adverse Event (IMAE) ADRENAL INSUFFICIENCY	1.1 Weeks Interval 1.1 to 1.1
Time to Resolution of High Grade Immune-Mediated Adverse Event (IMAE) RASH	10.07 Weeks Interval 5.0 to 15.1

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to approximately 15 months)

Population: All treated participants

Immune modulating medications are medications entered on an immune modulating medication form or available from the most current pre-defined list of immune modulating medications. This list is revisited whenever UMC WHO releases a new version and updated accordingly.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=101 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
The Number of Participants Who Received Immune-Modulating Medication	38 Participants

SECONDARY outcome

Timeframe: From first dose up to 100 days after last dose (up to approximately 15 months)

Population: All response evaluable participants - a total of 16 participants were excluded from "all response evaluable participants" population as they did not have measurable disease at baseline or at least 1 evaluable on-study assessment

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=85 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Objective Response Rate (ORR)	37.6 Percentage of participants Interval 27.4 to 48.8

SECONDARY outcome

Timeframe: From first dose to the date of CR or PR (up to approximately 15 months)

Population: All confirmed responders

TTR is defined as the time from the date of first dose to the date of the first confirmed documented response (CR or PR). For the non-responders, TTR was censored at the maximum time of response + 1 day of all participants. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=32 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Time to Response (TTR)	2.79 Months Interval 2.3 to 10.3

SECONDARY outcome

Timeframe: From first documented response (CR or PR) up to first documented progression or death due to any cause, whichever occurs first (up to approximately 3 years)

Population: All treated participants who have measurable disease at baseline and at least one on-study assessment

Duration of Response (DOR) is defined as the time between the date of first documented response (CR or PR) that was subsequently confirmed to the date of the first documented progression as determined using RECIST 1.1, or death due to any cause, whichever occurs first. For participants who neither progress nor die, the duration of response will be censored on the date of their last evaluable tumor assessment. For participants who start subsequent therapy before progression or die, the duration of response will be censored on the date of their last evaluable tumor assessment conducted on or prior to the initiation of the subsequent therapy. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Analysis based on Kaplan Meier estimates.

Outcome measures

Outcome measures
Measure	Nivolumab + Ipilimumab n=4 Participants Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Duration of Response (DoR)	NA Months Interval 1.3 to 9.9 Median not calculated due to not reaching the KM 50% threshold

Adverse Events

Nivolumab + Ipilimumab

Serious events: 37 serious events

Other events: 80 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab + Ipilimumab n=101 participants at risk Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Hepatobiliary disorders Bile duct stone	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Immune system disorders Contrast media reaction	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Bronchitis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Gastroenteritis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Sepsis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Septic shock	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Staphylococcal sepsis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Infections and infestations Upper respiratory tract infection	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Electrolyte imbalance	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hypocalcaemia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hypoglycaemia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hypokalaemia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hyponatraemia	5.0% 5/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Blood and lymphatic system disorders Anaemia	3.0% 3/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Cardiac disorders Acute coronary syndrome	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Cardiac disorders Cardiac arrest	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Cardiac disorders Myocardial infarction	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Cardiac disorders Myocardial ischaemia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Cardiac disorders Myocarditis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Endocrine disorders Adrenal insufficiency	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Endocrine disorders Hyperthyroidism	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Abdominal pain	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Stomatitis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Vomiting	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Death	2.0% 2/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Multiple organ dysfunction syndrome	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Pyrexia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	5.0% 5/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Nervous system disorders Altered state of consciousness	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Nervous system disorders Guillain-Barre syndrome	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Nervous system disorders Hemiparesis	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Nervous system disorders Hemiplegia	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Renal and urinary disorders Acute kidney injury	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Renal and urinary disorders Renal impairment	2.0% 2/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Reproductive system and breast disorders Acquired hydrocele	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 2/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 2/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.99% 1/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)

Other adverse events

Other adverse events
Measure	Nivolumab + Ipilimumab n=101 participants at risk Participants received nivolumab 3mg/kg Q3W combined with ipilimumab 1mg/kg Q3W for 4 doses followed by nivolumab 3mg/kg Q2W for up to 52 weeks.
Blood and lymphatic system disorders Anaemia	13.9% 14/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Endocrine disorders Hyperthyroidism	9.9% 10/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Endocrine disorders Hypothyroidism	9.9% 10/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Constipation	8.9% 9/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Diarrhoea	11.9% 12/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Gastrointestinal disorders Nausea	10.9% 11/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Asthenia	18.8% 19/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Fatigue	10.9% 11/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Pain	5.9% 6/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
General disorders Pyrexia	16.8% 17/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Investigations Blood creatinine increased	9.9% 10/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Investigations Weight increased	5.9% 6/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Decreased appetite	6.9% 7/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hyperglycaemia	5.9% 6/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Metabolism and nutrition disorders Hyponatraemia	8.9% 9/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Musculoskeletal and connective tissue disorders Back pain	12.9% 13/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Cough	24.8% 25/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 6/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Skin and subcutaneous tissue disorders Pruritus	20.8% 21/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Skin and subcutaneous tissue disorders Rash	11.9% 12/101 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 3 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Publication restrictions are in place

Restriction type: OTHER