Trial Outcomes & Findings for A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172) (NCT NCT02156804)
NCT ID: NCT02156804
Last Updated: 2020-09-11
Results Overview
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1009 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2020-09-11
Participant Flow
1009 participants were enrolled into the study , 1008 wrere treated, 1 participants was not treated due to withdrew consent
Participant milestones
| Measure |
Nivolumab 3mg/kg
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
1009
|
|
Overall Study
COMPLETED
|
1008
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Nivolumab 3mg/kg
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
Baseline characteristics by cohort
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
451 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
557 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
972 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
987 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All treated participants
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Gastrointestinal Adverse events (Grade 3-4)
|
16 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Gastrointestinal adverse events (Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Hepatic adverse events (Grade 3-4)
|
30 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Hepatic adverse events (Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Pulmonary adverse events(Grade 3-4)
|
6 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Pulmonary adverse events(Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Renal adverse events (Grade 3-4)
|
4 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Renal adverse events (Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Skin adverse events ( Grade 3-4)
|
13 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Skin adverse events ( Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Hypersensitivity adverse event( Grade 3-4)
|
1 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Hypersensitivity adverse event( Grade 5)
|
0 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Endocrine adverse events(Grade 3-4)
|
18 Number of Participants
|
|
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
Endocrine adverse events(Grade 5)
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All treated Participants
The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Gastrointestinal Adverse events (Grade 3-4)
|
24 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Gastrointestinal adverse events (Grade 5)
|
0 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Hepatic adverse events (Grade 3-4)
|
52 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Hepatic adverse events (Grade 5)
|
1 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Pulmonary adverse events(Grade 3-4)
|
7 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Pulmonary adverse events(Grade 5)
|
1 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Renal adverse events (Grade 3-4)
|
12 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Renal adverse events (Grade 5)
|
1 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Skin adverse events ( Grade 3-4)
|
19 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Skin adverse events ( Grade 5)
|
0 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Hypersensitivity adverse event( Grade 3-4)
|
2 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Hypersensitivity adverse event( Grade 5)
|
0 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Endocrine adverse events(Grade 3-4)
|
24 Number of Participants
|
|
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
Endocrine adverse events(Grade 5)
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Up to 2 years.Population: All Treated Participants.
Select AEs were summarized according to their incidence as well as their time to onset.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Endocrine Adverse Events
|
12 Weeks
Interval 0.3 to 88.4
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Gastrointestinal Adverse Events
|
23.50 Weeks
Interval 0.3 to 93.0
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Hepatic Adverse Events
|
10.14 Weeks
Interval 0.1 to 116.0
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Pulmonary Adverse Events
|
14.86 Weeks
Interval 1.3 to 64.9
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Renal Adverse Events
|
11.71 Weeks
Interval 1.1 to 60.0
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Skin Adverse Events
|
34.36 Weeks
Interval 1.1 to 88.0
|
|
Median Time to Onset (Grades 3-4) of Select Adverse Events
Hypersensitivity/infusion reaction Adverse Events
|
29.57 Weeks
Interval 29.57 to 29.57
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Treated Participants
Select AEs were summarized according to their incidence as well as their time to resolution
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Endocrine Adverse Events
|
2.43 Weeks
Interval 0.4 to 138.0
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Gastrointestinal Adverse Events
|
3.71 Weeks
Interval 0.1 to 85.9
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Hepatic Adverse Events
|
9.43 Weeks
Interval 0.1 to 128.1
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Pulmonary Adverse Events
|
2.57 Weeks
Interval 0.1 to 20.4
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Renal Adverse Events
|
1.93 Weeks
Interval 1.29 to 3.29
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Skin Adverse Events
|
5.07 Weeks
Interval 0.1 to 121.1
|
|
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Hypersensitivity/infusion reaction Adverse Events
|
0.29 Weeks
Interval 0.29 to 0.29
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All Treated Participants
The time from first dosing date to the date of death.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=1008 Participants
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Overall Survival
|
21.2 Months
Interval 18.2 to 24.4
|
Adverse Events
NIVOLUMAB 3 MG/KG IV
Serious events: 593 serious events
Other events: 857 other events
Deaths: 527 deaths
Serious adverse events
| Measure |
NIVOLUMAB 3 MG/KG IV
n=1008 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
10/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Angina pectoris
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Cardiac failure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Myocarditis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Pericardial effusion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Addison's disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Hyperthyroidism
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Hypophysitis
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Hypopituitarism
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Ectropion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Iridocyclitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Iritis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Macular hole
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Ulcerative keratitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Uveitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Vision blurred
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
13/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Ascites
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Colitis
|
0.69%
7/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Constipation
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
14/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Food poisoning
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Ileal perforation
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Intussusception
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Melaena
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Nausea
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
10/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Asthenia
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Chest pain
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Disease progression
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Fatigue
|
0.69%
7/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
General physical health deterioration
|
2.2%
22/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Generalised oedema
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Malaise
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Nodule
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Oedema peripheral
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Pyrexia
|
0.89%
9/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Sudden death
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Treatment failure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Jaundice
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Hepatobiliary disorders
Liver disorder
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Immune system disorders
Anaphylactic shock
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Immune system disorders
Autoimmune disorder
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Immune system disorders
Contrast media allergy
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Immune system disorders
Drug hypersensitivity
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Abdominal infection
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Abdominal sepsis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Anal abscess
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Appendiceal abscess
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Appendicitis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Arthritis bacterial
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Bronchitis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Cellulitis
|
0.60%
6/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Conjunctivitis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Cystitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Device related infection
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Device related sepsis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Diarrhoea infectious
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Enterocolitis infectious
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Erysipelas
|
0.69%
7/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Gastroenteritis
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Haematoma infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Infected dermal cyst
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Infected lymphocele
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Infection
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Influenza
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Latent tuberculosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.89%
9/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Lung infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Perirectal abscess
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Pneumococcal sepsis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Pneumonia
|
1.3%
13/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Pneumonia legionella
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Pseudomembranous colitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Respiratory tract infection
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Sepsis
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Septic encephalopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Sinusitis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Soft tissue infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Tonsillitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Tooth abscess
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Tooth infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Tracheobronchitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
11/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Urosepsis
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Vascular device infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Viral diarrhoea
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Viral infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Wound infection
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Dose calculation error
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Aspartate aminotransferase increased
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Blood creatinine increased
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
CSF test abnormal
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
General physical condition abnormal
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
International normalised ratio increased
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Lipase increased
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Pancreatic enzymes increased
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Transaminases increased
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Troponin T increased
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.69%
7/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.60%
6/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of spinal cord
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
27.6%
278/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.6%
16/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.50%
5/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
1.5%
15/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Altered state of consciousness
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Aphasia
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Brachial plexopathy
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Brain injury
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Brain oedema
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Central nervous system lesion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Cerebral haematoma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
7/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Encephalopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Epilepsy
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Facial paralysis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Facial paresis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Headache
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Hemiparesis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Miller Fisher syndrome
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Myasthenia gravis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Narcolepsy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Nervous system disorder
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Polyneuropathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Seizure
|
0.60%
6/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Sensorimotor disorder
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Spinal cord compression
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Status epilepticus
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Syncope
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Product Issues
Device dislocation
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Confusional state
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Depression
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Personality change
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Schizophrenia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.89%
9/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Bladder pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Postrenal failure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Renal failure
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Renal impairment
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Reproductive system and breast disorders
Penile oedema
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.79%
8/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.89%
9/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.99%
10/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
14/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Angiopathy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Circulatory collapse
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Embolism
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Extremity necrosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Hypertension
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Hypertensive crisis
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Hypotension
|
0.40%
4/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Jugular vein thrombosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Lymphoedema
|
0.30%
3/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Peripheral venous disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Superior vena cava syndrome
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Thrombosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Vascular occlusion
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Adrenal haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Retinal detachment
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Eye disorders
Vitreous haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Ileus
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Subileus
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.20%
2/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Gastroenteritis viral
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Gastrointestinal infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Meningitis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Septic shock
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Tuberculosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Lethargy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Neurological decompensation
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Sciatica
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Psychotic disorder
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory muscle weakness
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Vascular disorders
Lymphocele
|
0.10%
1/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
Other adverse events
| Measure |
NIVOLUMAB 3 MG/KG IV
n=1008 participants at risk
Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
126/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Endocrine disorders
Hypothyroidism
|
11.3%
114/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
10.1%
102/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
58/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Constipation
|
13.1%
132/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
210/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Nausea
|
21.0%
212/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
120/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Asthenia
|
16.7%
168/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Fatigue
|
29.3%
295/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Oedema peripheral
|
8.0%
81/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
General disorders
Pyrexia
|
12.9%
130/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
88/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Infections and infestations
Urinary tract infection
|
5.4%
54/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
83/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
78/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
5.2%
52/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Lipase increased
|
7.8%
79/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Investigations
Weight decreased
|
6.2%
63/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.2%
143/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
148/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
116/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
55/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
62/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
93/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Nervous system disorders
Headache
|
12.1%
122/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Psychiatric disorders
Insomnia
|
5.5%
55/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
134/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
81/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.4%
54/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.4%
115/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.8%
89/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
54/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
7.6%
77/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
51/1008 • Between first dose and 30 days after last dose ( up to 2 years)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60