Trial Outcomes & Findings for A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock. (NCT NCT02960854)

NCT ID: NCT02960854

Last Updated: 2019-04-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 38 participants
• Primary outcome timeframe: Screening, day -1, day 1 and subsequent days after, up to 90 days
• Results posted on: 2019-04-23

Participant Flow

38 subjects were enrolled in the study. 31 were randomized; 7 not randomized: (5) Failed to meet study eligibility criteria, (1) died, (1) withdrew consent

Participant milestones

Measure	Nivolumab (480 mg) the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Overall Study STARTED	15	16
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Measure	Nivolumab (480 mg) the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Overall Study Not Disclosed	2	2
Overall Study Subject No Longer Meets Study Criteria	1	0
Overall Study Subject Withdrew Consent	0	1
Overall Study Death	4	6

Baseline Characteristics

A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.

Baseline characteristics by cohort

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg	Total n=31 Participants Total of all reporting groups
Age, Continuous	56.6 Years STANDARD_DEVIATION 12.30 • n=93 Participants	58.4 Years STANDARD_DEVIATION 15.16 • n=4 Participants	57.5 Years STANDARD_DEVIATION 13.65 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	10 Participants n=4 Participants	21 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants	15 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Screening, day -1, day 1 and subsequent days after, up to 90 days

Population: All treated participants

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths AEs leading to discontinuation	0.0 Percentage	0.0 Percentage
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths Serious Adverse Events (SAEs)	6.7 Percentage	43.8 Percentage
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths Adverse Events (AEs)	93.3 Percentage	87.5 Percentage
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths Immune-Mediated Adverse Events	53.3 Percentage	81.3 Percentage
Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths Deaths	40.0 Percentage	38.7 Percentage

PRIMARY outcome

Timeframe: Screening up to 90 days (Discharge)

Population: All treated participants

Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Heart Rate (beats/min) Discharge	85.3 Percentage Standard Deviation 18.89	86.5 Percentage Standard Deviation 19.76
Composite of Vital Signs and Electrocardiogram (ECG) ECG Change from Baseline (Discharge)	-18.0 Percentage Standard Deviation 31.68	-29.0 Percentage Standard Deviation 3.46
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Diastolic Pressure (mmHg) Screening	61.5 Percentage Standard Deviation 20.37	58.5 Percentage Standard Deviation 9.00
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Systolic Pressure (mmHg) Screening	116.5 Percentage Standard Deviation 21.48	105.5 Percentage Standard Deviation 14.65
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Heart Rate (beats/min) Screening	80.1 Percentage Standard Deviation 21.34	94.6 Percentage Standard Deviation 16.64
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Resp. Rate (breaths/min) Screening	23.0 Percentage Standard Deviation 6.08	24.4 Percentage Standard Deviation 8.83
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Temperature (C) Screening	37.19 Percentage Standard Deviation 0.79	37.11 Percentage Standard Deviation 0.77
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Diastolic Pressure (mmHg) Discharge	79.7 Percentage Standard Deviation 16.49	70.5 Percentage Standard Deviation 16.28
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Systolic Pressure (mmHg) Discharge	129.0 Percentage Standard Deviation 25.06	110.0 Percentage Standard Deviation 16.47
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Resp. Rate (breaths/min) Discharge	18.8 Percentage Standard Deviation 2.71	17.5 Percentage Standard Deviation 3.32
Composite of Vital Signs and Electrocardiogram (ECG) Vital Signs - Temperature (C) Discharge	36.60 Percentage Standard Deviation 0.276	36.90 Percentage Standard Deviation 0.337

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated participants

Participants peak nivolumab serum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Peak Nivolumab Serum Concentration (Cmax)	123 ug/mL Geometric Coefficient of Variation 85.4	246 ug/mL Geometric Coefficient of Variation 85.4

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All treated participants

Participant trough nivolumab serum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Trough Nivolumab Serum Concentration (Cmin)	21.6 ug/mL Geometric Coefficient of Variation 39	43.2 ug/mL Geometric Coefficient of Variation 39

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All treated participants

Participant average nivolumab serum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Average Nivolumab Serum Concentration (Cavg)	42.7 ug/mL Geometric Coefficient of Variation 28.5	85.4 ug/mL Geometric Coefficient of Variation 28.5

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated participants

Participant observed time of maximum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Time of Maximum Observed Concentration (Tmax)	1.67 hours Interval 1.47 to 24.3	1.53 hours Interval 1.37 to 48.0

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated Participants

Area under the serum concentration-time curve from time zero to time of last quantifiable concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]	18099 h*ug/mL Geometric Coefficient of Variation 51	32130 h*ug/mL Geometric Coefficient of Variation 83

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated Participants

Total clearance of serum concentration of nivolumab

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Total Clearance (CLT)	0.025 L/h Geometric Coefficient of Variation 50	0.027 L/h Geometric Coefficient of Variation 85

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated Participants

Vlume of distribution of nivolumab serum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Volume of Distribution (Vd)	12.0 L Geometric Coefficient of Variation 42	13.3 L Geometric Coefficient of Variation 54

PRIMARY outcome

Timeframe: Day 1 and subsequent days after, up to 90 days

Population: All Treated Participants

Half-Life of nivolumab derived from serum concentration

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Half-life (T1/2)	353 hours Standard Deviation 126.5	378 hours Standard Deviation 189.6

SECONDARY outcome

Timeframe: Day 1 and up to day 90 (discharge)

Population: All Treated Participants

Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Receptor Occupancy Baseline	0.00 Percentage Standard Deviation 0.00	0.00 Percentage Standard Deviation 0.00
Receptor Occupancy Study Discharge	81.272 Percentage Standard Deviation 27.69	71.14 Percentage Standard Deviation 34.83

SECONDARY outcome

Timeframe: Baseline and subsequent days after, up to 90 days

Population: All Treated Participants

Participant with positive anti-drug antibody detection

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Number of Participants With Detectable Anti-nivolumab Antibodies	73.3 Percentage	75.0 Percentage

SECONDARY outcome

Timeframe: Baseline and subsequent days after, up to 90 days

Population: All Treated Participants

Outcome measures

Measure	Nivolumab (480 mg) n=15 Participants the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	Nivolumab (960 mg) n=16 Participants the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Number of Participants With Any Detectable Anti-drug Antibodies	26.7 Percentage	56.3 Percentage

Adverse Events

NIVOLUMAB 480mg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 4 deaths

NIVOLUMAB 960mg

Serious events: 7 serious events

Other events: 14 other events

Deaths: 6 deaths

Serious adverse events

Measure	NIVOLUMAB 480mg n=15 participants at risk the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	NIVOLUMAB 960mg n=16 participants at risk the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Blood and lymphatic system disorders Anaemia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Cardiac arrest	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Intra-abdominal haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Megacolon	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Multiple organ dysfunction syndrome	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Abdominal abscess	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Urosepsis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Electrocardiogram st segment elevation	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Acidosis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Ureterolithiasis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.

Other adverse events

Measure	NIVOLUMAB 480mg n=15 participants at risk the assessment of the safety and tolerability of a single dose of nivolumab 480 mg	NIVOLUMAB 960mg n=16 participants at risk the assessment of the safety and tolerability of a single dose of nivolumab 960 mg
Blood and lymphatic system disorders Anaemia	40.0% 6/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	50.0% 8/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Bandaemia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Coagulopathy	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Leukocytosis	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Atrial fibrillation	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Bradycardia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Bundle branch block right	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Cardiac arrest	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Cardiac failure	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Cardiomegaly	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Sinus bradycardia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Sinus node dysfunction	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Sinus tachycardia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Supraventricular tachycardia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Tachycardia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Cardiac disorders Ventricular extrasystoles	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Ear and labyrinth disorders Mastoid effusion	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Endocrine disorders Hypothyroidism	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Eye disorders Corneal epithelium defect	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Eye disorders Macular degeneration	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Eye disorders Periorbital oedema	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Eye disorders Pupils unequal	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Abdominal distension	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Diarrhoea	33.3% 5/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Dyspepsia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Dysphagia	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Flatulence	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Gastrointestinal fistula	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Gastrointestinal haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Haematochezia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Ileus	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Inguinal hernia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Intra-abdominal fluid collection	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Melaena	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Nausea	26.7% 4/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Pancreatitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Rectal haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Swollen tongue	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Gastrointestinal disorders Vomiting	20.0% 3/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Asthenia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Catheter site haematoma	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Catheter site haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Chest pain	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Face oedema	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Fatigue	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Generalised oedema	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Oedema	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Oedema peripheral	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Pain	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Peripheral swelling	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Pyrexia	33.3% 5/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	37.5% 6/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
General disorders Secretion discharge	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Cholecystitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Cholelithiasis	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hepatic cirrhosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hepatic lesion	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hepatic steatosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hepatitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hepatomegaly	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Hepatobiliary disorders Porcelain gallbladder	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Abdominal infection	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Candida infection	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Cellulitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Conjunctivitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Genital infection fungal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Herpes dermatitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Herpes simplex	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Impetigo	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Lung infection	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Oral candidiasis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Oral herpes	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Osteomyelitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Pneumonia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Purulent discharge	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Staphylococcal infection	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Subcutaneous abscess	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Tracheitis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Urinary tract infection	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Urinary tract infection bacterial	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Viral tracheitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Viral upper respiratory tract infection	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Infections and infestations Wound infection	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Excoriation	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Foreign body	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Limb injury	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Procedural haemorrhage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Stoma site discharge	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Subcutaneous haematoma	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Alanine aminotransferase abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Alanine aminotransferase increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Ammonia increased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Amylase increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Aspartate aminotransferase abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Aspartate aminotransferase increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Bacterial test positive	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood alkaline phosphatase increased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood bilirubin abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood bilirubin increased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood creatinine increased	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood glucose increased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood lactate dehydrogenase increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood potassium increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Blood pressure increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Brain natriuretic peptide increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Breath sounds abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Bronchoalveolar lavage abnormal	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations C-reactive protein increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Chest x-ray abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Clostridium test positive	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Ejection fraction decreased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Electrocardiogram qt prolonged	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Fungal test positive	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Gastric ph increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Glycosylated haemoglobin increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Haemoglobin decreased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Hepatic enzyme increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Herpes simplex test positive	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations International normalised ratio increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Lipase increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Liver function test abnormal	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Oxygen saturation decreased	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Reticulocyte count increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Sputum culture positive	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Staphylococcus test positive	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Transaminases increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Urine output decreased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations Weight decreased	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Investigations White blood cell count increased	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Acidosis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Fluid overload	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Gout	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hyperglycaemia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypernatraemia	20.0% 3/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hyperphosphataemia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypoalbuminaemia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypocalcaemia	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypomagnesaemia	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hyponatraemia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Hypophosphataemia	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Malnutrition	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Metabolic alkalosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Metabolism and nutrition disorders Polydipsia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Joint effusion	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Muscle atrophy	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Muscle necrosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Cerebrospinal fluid leakage	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Dizziness	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Encephalopathy	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Facial paresis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Lethargy	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Neuropathy peripheral	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Presyncope	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Nervous system disorders Somnolence	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Product Issues Thrombosis in device	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Agitation	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Anxiety	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Delirium	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Depression	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Insomnia	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Mental status changes	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Psychiatric disorders Nightmare	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Acute kidney injury	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Haematuria	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Oliguria	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Polyuria	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Renal and urinary disorders Renal failure	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Reproductive system and breast disorders Acquired phimosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Reproductive system and breast disorders Prostatic obstruction	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Reproductive system and breast disorders Scrotal oedema	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Apnoeic attack	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Hypoxia	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	18.8% 3/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Lung disorder	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 3/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	31.2% 5/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Pneumothorax	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Tachypnoea	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Decubitus ulcer	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Dermatitis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Rash vesicular	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Skin discolouration	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Skin and subcutaneous tissue disorders Skin ulcer	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Deep vein thrombosis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	12.5% 2/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Dry gangrene	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Extremity necrosis	0.00% 0/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Flushing	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Hypertension	13.3% 2/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	6.2% 1/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Hypotension	40.0% 6/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	25.0% 4/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Labile blood pressure	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Shock haemorrhagic	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.
Vascular disorders Thrombosis	6.7% 1/15 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.	0.00% 0/16 • Adverse events (AEs) and serious adverse events (SAEs) were collected from Day 1 following single dose of nivolumab, up until Day 90.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

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

Restriction type: OTHER