Trial Outcomes & Findings for Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy (NCT NCT04326257)

NCT ID: NCT04326257

Last Updated: 2026-01-08

Results Overview

The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: From start of treatment, up to 36 months
• Results posted on: 2026-01-08

Participant Flow

Participant milestones

Measure	Selected Treatment Nivolumab+Relatlimab: Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment Nivolumab+Relatlimab: Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Overall Study STARTED	7	13
Overall Study Nivolumab+Relatlimab	7	6
Overall Study Nivolumab+Ipilimumab	0	7
Overall Study COMPLETED	7	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy

Baseline characteristics by cohort

Measure	Selected Treatment n=7 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=13 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Total n=20 Participants Total of all reporting groups
Age, Continuous	62.86 years STANDARD_DEVIATION 9.974 • n=18 Participants	63.62 years STANDARD_DEVIATION 7.633 • n=17 Participants	63.35 years STANDARD_DEVIATION 8.267 • n=35 Participants
Sex: Female, Male Female	0 Participants n=18 Participants	2 Participants n=17 Participants	2 Participants n=35 Participants
Sex: Female, Male Male	7 Participants n=18 Participants	11 Participants n=17 Participants	18 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=18 Participants	13 Participants n=17 Participants	20 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) White	7 Participants n=18 Participants	13 Participants n=17 Participants	20 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: From start of treatment, up to 36 months

Population: Treated patients who were radiologically evaluable. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Selected Treatment n=7 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Probability of Objective Response (OR) - Selected Treatment	0 percentage of patients	—

SECONDARY outcome

Timeframe: From start of treatment, up to 36 months

Population: Treated patients who were radiologically evaluable. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

The probability of response to therapy in patients who have progressed on prior immunotherapy. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Selected Treatment n=7 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Probability of Objective Response (OR) - Randomized Treatment	0 percentage of patients	—

SECONDARY outcome

Timeframe: From start of treatment, up to 36 months

Population: Treated patients evaluable for radiologic response. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

The percent probability of not experiencing disease progression in patients regardless of selected/randomized treatment. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.

Outcome measures

Measure	Selected Treatment n=6 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=12 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Disease Control Rate (DCR)	33.3 percent probability of participants Interval 9.7 to 70.0	25.0 percent probability of participants Interval 8.9 to 53.2

SECONDARY outcome

Timeframe: From start of treatment up to 36 months

Population: Treated patients evaluable for radiologic response. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

The length of time from the start of treatment that patients live with disease that does not progress per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients who have progressed on prior immunotherapy. Per RECIST, Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions.It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Selected Treatment n=6 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=11 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Progression-free Survival (PFS)	52.00 Days Interval 31.6 to 72.4	53.00 Days Interval 50.92 to 55.09

SECONDARY outcome

Timeframe: From start of treatment, up to 36 months

Population: All enrolled patients. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

The length of time from the start of treatment that patients remain alive, in patients who have progressed on prior immunotherapy.

Outcome measures

Measure	Selected Treatment n=5 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=6 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Overall Survival (OS)	166.00 Days Interval 22.92 to 309.08	164.00 Days Interval 0.0 to 379.6

SECONDARY outcome

Timeframe: From start of treatment, up to 36 months

Population: Treated patients evaluable for radiologic response. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

Mean number of months that patients who had Stable Disease experienced disease control. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Stable Disease (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.

Outcome measures

Measure	Selected Treatment n=2 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=3 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Duration of Disease Control	133.50 Days Standard Deviation 122.33	97.67 Days Standard Deviation 81.82

SECONDARY outcome

Timeframe: From start of treatment, up to 36 months

Population: Distinct number of treated patients. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

Adverse Events possibly, probably or definitely related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 experienced.

Outcome measures

Measure	Selected Treatment n=13 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.	Randomized Treatment n=7 Participants Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Or, Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients will receive four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. A cycle of therapy will be defined as 4 weeks of treatment. The patient will receive the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation.
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Hyperglycemia	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Hypoalbuminemia	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Hyponatremia	2 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Hypophosphatemia	2 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Lymphocyte count decreased	3 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Platelet count decreased	1 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 psoriasis	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Tumor hemorrhage	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Vomiting	1 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Weight loss	0 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Rash maculo-papular	0 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Pneumonitis	0 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Diarrhea	0 patients	2 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Flushing	0 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Fatigue	2 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Cough	0 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Creatinine increased	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Alanine aminotransferase increased	3 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Alkaline phosphatase increased	2 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Anemia	2 patients	2 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Anorexia	1 patients	0 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Aspartate aminotransferase increased	3 patients	1 patients
Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 PACs on EKG	1 patients	0 patients

Adverse Events

Nivolumab+Relatlimab

Serious events: 11 serious events

Other events: 10 other events

Deaths: 12 deaths

Nivolumab+Ipilimumab

Serious events: 6 serious events

Other events: 6 other events

Deaths: 4 deaths

Serious adverse events

Measure	Nivolumab+Relatlimab n=13 participants at risk Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients received the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab	Nivolumab+Ipilimumab n=7 participants at risk Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients received four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. One cycle of therapy will be defined as 4 weeks of treatment. Patients received the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Activated partial thromboplastin time prolonged	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Agitation	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Alanine aminotransferase increased	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Alkaline phosphatase increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Blood and lymphatic system disorders Anemia	76.9% 10/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	85.7% 6/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Anorexia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Anxiety	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Aspartate aminotransferase increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Atrial fibrillation	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Atrial flutter	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Blood bilirubin increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Blood lactate dehydrogenase increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Blood and lymphatic system disorders Bone marrow hypocellular	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyCoronary artery disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyPACs on EKG	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyright bundle branch block	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Cardiac troponin I increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Cholesterol high	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Renal and urinary disorders Chronic kidney disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Confusion	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Constipation	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Creatinine increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Depression	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Diarrhea	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Dysarthria	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Dysgeusia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Dyspnea	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specifyR ear drainage ottorrhea	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Ear pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Esophagitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Facial pain	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Fatigue	46.2% 6/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	57.1% 4/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Fever	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Gait disturbance	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastroesophageal reflux disease	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyDiverticulitis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyDuodenitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders General disorders and administration site conditions - Other, specifyFailure to thrive	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Headache	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Hearing impaired	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypercalcemia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperglycemia	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperlipidemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Hypertension	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	57.1% 4/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypoalbuminemia	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypomagnesemia	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyponatremia	46.2% 6/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	85.7% 6/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypophosphatemia	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Hypotension	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Endocrine disorders Hypothyroidism	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	71.4% 5/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Immune system disorders Immune system disorders - Other, specifyCeliacs disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Infections and infestations - Other, specifyRight neck	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Infections and infestations - Other, specifyThrush	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyLeft neck wound, biopsy site	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyRadiation fibrosis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations INR increased	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Insomnia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyalbumin decrease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyBlood bicarbonate decrease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyIncreased LDH	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyVitamin D deficiency	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Lung infection	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Lymphedema	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Lymphocyte count decreased	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyHyperphosphatemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyType II Diabetes	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifymuscle cramp	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyosteoarthritis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyosteomyelitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Nausea	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyBone Metastases	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyLipomas	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Nervous system disorders - Other, specifydestruction of facial nerves	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Non-cardiac chest pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Oral pain	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Pain	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Peripheral motor neuropathy	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Peripheral sensory neuropathy	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Platelet count decreased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Rash acneiform	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyParalyzed diaphragm	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyPneumonia	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifytrach secretions	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Sepsis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Sinus bradycardia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifypharyngeal erythema	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifypsoriasis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifySeborrhea capitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Skin infection	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Sleep apnea	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Stomach pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Surgical and medical procedures Surgical and medical procedures - Other, specifyL sided neck dissection	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Surgical and medical procedures Surgical and medical procedures - Other, specifyThymectomy of mediastinal Mass	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Tinnitus	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Tremor	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Trismus	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Vascular disorders - Other, specifyDeep vein thrombosis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Weight loss	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations White blood cell decreased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

Other adverse events

Measure	Nivolumab+Relatlimab n=13 participants at risk Nivolumab will be dosed 480mg IV q 4 weeks and Relatlimab 160mg IV q 4 weeks One cycle is defined as 4 weeks of treatment and both drugs are given on the same day. Patients received the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Nivolumab+Relatlimab: IV administration of both Nivolumab and Relatlimab	Nivolumab+Ipilimumab n=7 participants at risk Nivolumab will be dosed at 3mg/kg IV q 2 weeks and Ipilimumab 1mg/kg IV q 6 weeks. Patients received four doses of Ipilimumab and the last dosage of Nivolumab 3mg/kg IV q 2 weeks will be given at the time of the 4th dose of Ipilimumab, followed 2 weeks later by Nivolumab 480 mg IV q 4 weeks. One cycle of therapy will be defined as 4 weeks of treatment. Patients received the prescribed therapy continuously for up to 24 cycles until progression of disease or adverse event(s) requiring treatment discontinuation. Nivolumab+Ipilimumab: IV administration of both Nivolumab and Ipilimumab
Metabolism and nutrition disorders Anorexia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Anxiety	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Diarrhea	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Aspartate aminotransferase increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Dysarthria	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Dysgeusia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Atrial fibrillation	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Atrial flutter	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Blood bilirubin increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Blood lactate dehydrogenase increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Blood and lymphatic system disorders Bone marrow hypocellular	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Creatinine increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Depression	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Activated partial thromboplastin time prolonged	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Agitation	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Alanine aminotransferase increased	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Alkaline phosphatase increased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Blood and lymphatic system disorders Anemia	76.9% 10/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	85.7% 6/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyCoronary artery disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyPACs on EKG	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Cardiac disorders - Other, specifyright bundle branch block	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Cardiac troponin I increased	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Cholesterol high	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Renal and urinary disorders Chronic kidney disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Confusion	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Constipation	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Dyspnea	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specifyR ear drainage ottorrhea	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Ear pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Esophagitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Facial pain	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Fatigue	46.2% 6/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	57.1% 4/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Fever	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Gait disturbance	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastroesophageal reflux disease	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyDiverticulitis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyDuodenitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders General disorders and administration site conditions - Other, specifyFailure to thrive	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Headache	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Hearing impaired	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypercalcemia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperglycemia	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyperlipidemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Hypertension	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	57.1% 4/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypoalbuminemia	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypomagnesemia	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hyponatremia	46.2% 6/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	85.7% 6/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Hypophosphatemia	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Hypotension	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Endocrine disorders Hypothyroidism	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	71.4% 5/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Immune system disorders Immune system disorders - Other, specifyCeliacs disease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Infections and infestations - Other, specifyRight neck	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Infections and infestations - Other, specifyThrush	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyLeft neck wound, biopsy site	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specifyRadiation fibrosis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations INR increased	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Psychiatric disorders Insomnia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyalbumin decrease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyBlood bicarbonate decrease	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyIncreased LDH	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Investigations - Other, specifyVitamin D deficiency	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Lung infection	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Lymphedema	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Lymphocyte count decreased	38.5% 5/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	42.9% 3/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyHyperphosphatemia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specifyType II Diabetes	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifymuscle cramp	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyosteoarthritis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyosteomyelitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Nausea	30.8% 4/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyBone Metastases	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyLipomas	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Nervous system disorders - Other, specifydestruction of facial nerves	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Non-cardiac chest pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Oral pain	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
General disorders Pain	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Peripheral motor neuropathy	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Peripheral sensory neuropathy	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Platelet count decreased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Rash acneiform	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyCOPD	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyParalyzed diaphragm	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyPneumonia	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifytrach secretions	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Sepsis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Sinus bradycardia	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifypharyngeal erythema	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders psoriasis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifySeborrhea capitis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Infections and infestations Skin infection	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Sleep apnea	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	28.6% 2/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Stomach pain	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Surgical and medical procedures Surgical and medical procedures - Other, specifyL sided neck dissection	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Surgical and medical procedures Surgical and medical procedures - Other, specifyThymectomy of mediastinal Mass	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Ear and labyrinth disorders Tinnitus	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Nervous system disorders Tremor	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Musculoskeletal and connective tissue disorders Trismus	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Vascular disorders - Other, specifyDeep vein thrombosis	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations Weight loss	15.4% 2/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Investigations White blood cell decreased	23.1% 3/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Cardiac disorders PACs on EKG	7.7% 1/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	0.00% 0/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Vascular disorders Flushing	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/13 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.	14.3% 1/7 • Adverse Events data were collected for up to 36 months. All-Cause Mortality data was collected for up to 46 months. It was pre-specified to report data per the two groups of interest, "selected" or "randomized," without specific drug combinations.

Additional Information

Barbara Stadterman, MPH, CCRP

UPMC

Phone: 7245532539

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place