Trial Outcomes & Findings for Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer (NCT NCT03090737)

Last Updated: 2022-12-05

Results Overview

The number of participants who experienced at least 1 select AE of Grade 3-5, judged to be related to study drug per investigator with onset on or after first dose of study treatment and within 30 days of last dose of study treatment, divided by number of treated participants. AE grade is defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 criteria. The select AEs consist of pulmonary events, gastrointestinal events, hepatic events, renal events, skin events, endocrine events categories, thyroid disorders, diabetes, pituitary, adrenal disorder subcategories. Grade 3 is defined as severe or medically significant but not immediately life-threatening. Grade 4 is defined as life-threatening consequences and urgent intervention indicated. Grade 5 is defined as death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)

Results posted on

2022-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Nivolumab 480mg Q4W 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Overall Study STARTED	129
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	129

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab 480mg Q4W 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Overall Study Other reasons	1
Overall Study Completed treatment as per protocol	17
Overall Study Maximum clinical benefit	2
Overall Study Adverse event unrelated to study drug	7
Overall Study Study drug toxicity	4
Overall Study Disease progression	98

Baseline Characteristics

Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Age, Continuous	61.8 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 24 months)

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) Total Participants with Grade 3-4 AE	3 Participants
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) Total Participants with Grade 5 AE	0 Participants

SECONDARY outcome

Timeframe: From first dose to the date of the first documented tumor progression (up to approximately 5 months)

Population: All Treated Participants

Progression free survival (PFS) is defined as the time between the date of randomization and the date of the first documented tumor progression accounting for subsequent therapy, based on BICR (blinded independent central review) assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants will be censored at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Progression Free Survival (PFS)	3.68 Months Interval 3.06 to 4.5

SECONDARY outcome

Timeframe: From the date of first dose to the date of the initial objectively documented tumor progression or the date of subsequent therapy, whichever occurs first (up to approximately 25 months).

Population: All Treated Participants

Objective Response Rate (ORR) defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator per RECIST 1.1. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Radiographic tumor assessments will be conducted at Week 8 (+/- 7 days) and every 8 weeks (+/- 7 days) until up to 2 years or until disease progression (or until discontinuation of study therapy in patients receiving nivolumab beyond progression), lost to follow-up, or withdrawal of study consent.

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Objective Response Rate (ORR)	17.1 Percentage of participants Interval 11.0 to 24.7

SECONDARY outcome

Timeframe: From first dosing date and the date of death due to any cause (up to approximately 4 years and 9 months)

Population: All Treated Participants

Overall Survival (OS) is defined as the time between the first dosing date and the date of death due to any cause. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Overall Survival (OS)	10.58 Months Interval 8.34 to 14.69

SECONDARY outcome

Timeframe: From the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1), or death due to any cause, whichever occurs first (up to approximately 48 months).

Population: All Responder Participants (participants with confirmed CR or PR)

Duration of Response (DOR) is defined as the time between the date of first confirmed response up to the date of the first documented tumor progression (per RECIST 1.1) as determined by complete response (CR) or partial response (PR), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including palliative local therapy) without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of the subsequent anti-cancer therapy (including palliative local therapy). Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=22 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Duration of Response (DOR)	35.45 Months Interval 10.87 to 47.31

POST_HOC outcome

Timeframe: From the first dose of study treatment to up to 30 days of the last dose of study treatment (up to 25 months)

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Nivolumab 480mg Q4W n=129 Participants 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) - Extended Collection Total Participants with Grade 3-4 AE	6 Participants
The Number of Participants Experiencing High Grade (Grades 3-4 and Grade 5) Drug-Related Select Adverse Events (AE) - Extended Collection Total Participants with Grade 5 AE	0 Participants

Adverse Events

Nivolumab 480mg Q4W

Serious events: 56 serious events

Other events: 111 other events

Deaths: 105 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab 480mg Q4W n=129 participants at risk 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Blood and lymphatic system disorders Anaemia	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Blood and lymphatic system disorders Pancytopenia	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Cardiac disorders Cardiac tamponade	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Colitis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Nausea	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Oesophageal ulcer	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Vomiting	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders General physical health deterioration	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders Non-cardiac chest pain	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Hepatobiliary disorders Cholecystitis acute	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Hepatobiliary disorders Cholecystitis chronic	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Diverticulitis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Empyema	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Gastroenteritis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Influenza	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Lower respiratory tract infection	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Orchitis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Pneumonia	4.7% 6/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Pneumonia aspiration	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Pneumonia klebsiella	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Pulmonary tuberculosis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Sepsis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Urinary tract infection bacterial	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Injury, poisoning and procedural complications Femoral neck fracture	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Injury, poisoning and procedural complications Spinal compression fracture	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Injury, poisoning and procedural complications Tendon rupture	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Influenza A virus test positive	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hyperglycaemia	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hypomagnesaemia	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Musculoskeletal and connective tissue disorders Bone pain	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	28.7% 37/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Nervous system disorders Amnesia	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Renal and urinary disorders Acute kidney injury	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Renal and urinary disorders Nephrolithiasis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Renal and urinary disorders Renal impairment	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.6% 2/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Vascular disorders Deep vein thrombosis	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Vascular disorders Haemorrhage	0.78% 1/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)

Other adverse events

Other adverse events
Measure	Nivolumab 480mg Q4W n=129 participants at risk 480 mg of Nivolumab every 4 weeks (Q4W) until progression, unacceptable toxicity, withdrawal of consent, death, or a max of 2 years, whichever occurs first
Blood and lymphatic system disorders Anaemia	28.7% 37/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Endocrine disorders Hyperthyroidism	5.4% 7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Endocrine disorders Hypothyroidism	6.2% 8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Constipation	7.0% 9/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Diarrhoea	18.6% 24/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Nausea	17.1% 22/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Gastrointestinal disorders Vomiting	9.3% 12/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders Asthenia	6.2% 8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders Fatigue	14.7% 19/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders Non-cardiac chest pain	7.8% 10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
General disorders Oedema peripheral	6.2% 8/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Pneumonia	10.1% 13/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Infections and infestations Upper respiratory tract infection	5.4% 7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Alanine aminotransferase increased	9.3% 12/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Aspartate aminotransferase increased	8.5% 11/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Blood alkaline phosphatase increased	24.8% 32/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Blood creatinine increased	8.5% 11/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Investigations Weight decreased	10.9% 14/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Decreased appetite	16.3% 21/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hyperglycaemia	10.1% 13/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hypoalbuminaemia	11.6% 15/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hypomagnesaemia	7.8% 10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Metabolism and nutrition disorders Hyponatraemia	10.9% 14/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Musculoskeletal and connective tissue disorders Back pain	7.8% 10/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Nervous system disorders Dizziness	5.4% 7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Nervous system disorders Headache	13.2% 17/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Psychiatric disorders Anxiety	5.4% 7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Cough	12.4% 16/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.8% 23/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Skin and subcutaneous tissue disorders Dry skin	5.4% 7/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Skin and subcutaneous tissue disorders Erythema	7.0% 9/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Skin and subcutaneous tissue disorders Pruritus	18.6% 24/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 months)
Skin and subcutaneous tissue disorders Rash	20.2% 26/129 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 4 years and 9 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 27 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