Trial Outcomes & Findings for Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (NCT NCT03937219)
NCT ID: NCT03937219
Last Updated: 2025-09-10
Results Overview
Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause. PFS (months) = (earliest date of progression, death, censoring - date of randomization + 1)/30.4375. PFS was determined as per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
855 participants
Primary outcome timeframe
Up to 32 months
Results posted on
2025-09-10
Participant Flow
The results reported in this study are based upon the data cutoff date of 09 May 2024.
Participant milestones
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
Participants received cabozantinib 40 milligrams (mg) orally once daily (qd) + 4 doses of nivolumab 3 milligrams/kilograms (mg/kg) infusion once every 3 weeks (q3w) + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion once every 4 weeks (q4w).
|
Placebo + Nivolumab + Ipilimumab
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Overall Study
STARTED
|
428
|
427
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
426
|
423
|
|
Overall Study
Progression Free Survival (PFS) Intent-to-Treat (PITT) Population
|
276
|
274
|
|
Overall Study
Safety Analysis Set
|
426
|
423
|
|
Overall Study
Intent to Treat (ITT) Population
|
428
|
427
|
|
Overall Study
COMPLETED
|
185
|
187
|
|
Overall Study
NOT COMPLETED
|
243
|
240
|
Reasons for withdrawal
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
Participants received cabozantinib 40 milligrams (mg) orally once daily (qd) + 4 doses of nivolumab 3 milligrams/kilograms (mg/kg) infusion once every 3 weeks (q3w) + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion once every 4 weeks (q4w).
|
Placebo + Nivolumab + Ipilimumab
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Overall Study
Death
|
223
|
211
|
|
Overall Study
Withdrawal by Subject
|
17
|
25
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Total
n=855 Participants
Total of all reporting groups
|
Cabozantinib + Nivolumab + Ipilimumab
n=428 Participants
Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w.
|
Placebo + Nivolumab + Ipilimumab
n=427 Participants
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
553 Participants
n=206 Participants
|
277 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
|
Age, Categorical
>=65 years
|
302 Participants
n=206 Participants
|
151 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=206 Participants
|
102 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
638 Participants
n=206 Participants
|
326 Participants
n=99 Participants
|
312 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
257 Participants
n=206 Participants
|
130 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
536 Participants
n=206 Participants
|
263 Participants
n=99 Participants
|
273 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=206 Participants
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=206 Participants
|
29 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=206 Participants
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
670 Participants
n=206 Participants
|
339 Participants
n=99 Participants
|
331 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
94 Participants
n=206 Participants
|
51 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
PRIMARY outcome
Timeframe: Up to 32 monthsPopulation: PFS Intent-to-Treat (PITT) population was defined as the first 550 randomized participants regardless of whether any study treatment or the correct study treatment was received. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause. PFS (months) = (earliest date of progression, death, censoring - date of randomization + 1)/30.4375. PFS was determined as per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.
Outcome measures
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
n=116 Participants
Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w.
|
Placebo + Nivolumab + Ipilimumab
n=133 Participants
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)
|
NA months
Interval 14.0 to
NA signifies that the median and upper limit of 95% CI was not estimable due to a low number of events observed.
|
11.30 months
Interval 7.69 to 18.17
|
SECONDARY outcome
Timeframe: Up to 58 monthsPopulation: The ITT population was defined as all randomized participants regardless of whether any study treatment or the correct study treatment was received. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Duration of OS (months) = (earliest date of death or censoring - date of randomization + 1)/30.4375.
Outcome measures
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
n=226 Participants
Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w.
|
Placebo + Nivolumab + Ipilimumab
n=217 Participants
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Duration of Overall Survival (OS)
|
41.86 months
Interval 34.79 to 47.87
|
41.99 months
Interval 34.92 to 53.13
|
Adverse Events
Cabozantinib + Nivolumab + Ipilimumab
Serious events: 272 serious events
Other events: 421 other events
Deaths: 224 deaths
Placebo + Nivolumab + Ipilimumab
Serious events: 257 serious events
Other events: 416 other events
Deaths: 217 deaths
Serious adverse events
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
n=426 participants at risk
Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w.
|
Placebo + Nivolumab + Ipilimumab
n=423 participants at risk
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Investigations
Transaminases increased
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.94%
4/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.2%
5/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Acquired factor VIII deficiency
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
6/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.4%
6/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Myocarditis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Cardiotoxicity
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Arrhythmia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.6%
11/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.8%
12/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Hypophysitis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.7%
7/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Hypopituitarism
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Eye disorders
Diplopia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Eye disorders
Iridocyclitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Eye disorders
Orbital myositis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Eye disorders
Uveitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
14/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.0%
17/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.4%
10/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.1%
9/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.2%
5/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.4%
6/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Ascites
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Anal fistula
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Ileus
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Jejunal ulcer
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Malabsorption
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Protein-losing gastroenteropathy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Pyrexia
|
2.1%
9/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
General physical health deterioration
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.4%
6/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Asthenia
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Death
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Fatigue
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Disease progression
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Chest pain
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Sudden death
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Pain
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Chest discomfort
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Condition aggravated
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Crepitations
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Performance status decreased
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Swelling face
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Ulcer
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
4.7%
20/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
7/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hepatitis
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.94%
4/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Jaundice
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Immune system disorders
Anaphylactic reaction
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Immune system disorders
Autoimmune disorder
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Immune system disorders
Cytokine release syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
COVID-19
|
3.8%
16/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.0%
17/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pneumonia
|
3.1%
13/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.4%
10/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Sepsis
|
1.4%
6/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.2%
5/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Anal abscess
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Septic shock
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Empyema
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Meningitis aseptic
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pneumonia bacterial
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Urosepsis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Abdominal infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Abdominal wall abscess
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Campylobacter infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Conjunctivitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Device related sepsis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Encephalitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Epididymitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Human anaplasmosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Infected fistula
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Influenza
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Mastoiditis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Meningitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Peritonitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Rectal abscess
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Scrotal infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Skin infection
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Sciatic nerve injury
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
10.6%
45/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.6%
11/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
8.0%
34/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.1%
13/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Lipase increased
|
1.4%
6/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood bilirubin increased
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood creatinine increased
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Amylase increased
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Hepatic enzyme increased
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Glomerular filtration rate decreased
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Haemoglobin increased
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Troponin I increased
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Troponin T increased
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Troponin increased
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Weight decreased
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
8/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.9%
8/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.7%
7/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Cell death
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.7%
7/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
3.1%
13/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.5%
15/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.9%
8/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Seizure
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Dizziness
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Brain oedema
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Headache
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Spinal cord compression
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Cervical cord compression
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Embolic cerebellar infarction
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Epilepsy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Loss of consciousness
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Optic neuritis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Psychiatric disorders
Emotional distress
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Psychiatric disorders
Panic disorder
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
7/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.4%
6/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Renal failure
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Nephritis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Urinary retention
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Proteinuria
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Reproductive system and breast disorders
Paraphimosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
8/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.9%
8/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
4/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.1%
9/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
5/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.2%
5/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
4/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.95%
4/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.71%
3/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.70%
3/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Autoimmune lung disease
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosa atrophy
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
6/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.47%
2/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
7/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Hypertension
|
0.47%
2/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Hypotension
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Aortic stenosis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Cyanosis
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Essential hypertension
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Haematoma
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Lymphoedema
|
0.23%
1/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.00%
0/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
0.24%
1/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
Other adverse events
| Measure |
Cabozantinib + Nivolumab + Ipilimumab
n=426 participants at risk
Participants received cabozantinib 40 mg orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib 40 mg orally qd + nivolumab 480 mg infusion q4w.
|
Placebo + Nivolumab + Ipilimumab
n=423 participants at risk
Participants received cabozantinib matched placebo orally qd + 4 doses of nivolumab 3 mg/kg infusion q3w + 4 doses of ipilimumab 1 mg/kg infusion q3w followed by cabozantinib matched placebo orally qd + nivolumab 480 mg infusion q4w.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
29.3%
125/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
10.6%
45/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
26/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.8%
16/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.3%
27/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.6%
11/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
25/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.4%
10/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.5%
96/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
22.7%
96/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
62/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
16.1%
68/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
46/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.2%
39/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
32/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
7.8%
33/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.0%
47/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.1%
9/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Headache
|
16.4%
70/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
15.4%
65/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Dizziness
|
8.9%
38/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.0%
38/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Nervous system disorders
Dysgeusia
|
10.6%
45/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.8%
16/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Psychiatric disorders
Insomnia
|
10.1%
43/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
8.0%
34/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Proteinuria
|
9.9%
42/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
10.2%
43/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Renal and urinary disorders
Haematuria
|
7.0%
30/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.7%
24/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
66/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
14.7%
62/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
46/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.7%
41/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
61/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.3%
14/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.9%
106/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
31.0%
131/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.6%
105/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
22.9%
97/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
28.9%
123/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
6.1%
26/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.3%
31/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.9%
25/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.6%
28/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.0%
17/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.1%
77/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
22.2%
94/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
29/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.8%
12/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
23/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
1.4%
6/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
122/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
19.1%
81/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
12.7%
54/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
11.3%
48/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.7%
216/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
25.5%
108/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
112/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
24.8%
105/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
78/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
15.6%
66/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
64/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
15.6%
66/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.9%
72/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.7%
41/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Stomatitis
|
16.0%
68/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.6%
11/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Dry mouth
|
8.9%
38/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.5%
40/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
44/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.4%
23/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
28/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.9%
25/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.8%
29/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.8%
12/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Fatigue
|
31.2%
133/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
30.5%
129/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Asthenia
|
24.2%
103/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
16.1%
68/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Pyrexia
|
18.3%
78/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
14.4%
61/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Oedema peripheral
|
10.1%
43/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
8.5%
36/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Mucosal inflammation
|
11.7%
50/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.0%
17/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
General disorders
Chest pain
|
3.8%
16/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.9%
25/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.6%
24/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.4%
10/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
COVID-19
|
14.6%
62/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
12.3%
52/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
9.9%
42/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
8.0%
34/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
47.9%
204/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
21.0%
89/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
45.8%
195/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
17.5%
74/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Lipase increased
|
24.9%
106/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
18.4%
78/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Amylase increased
|
23.5%
100/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
15.6%
66/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood creatinine increased
|
16.0%
68/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
14.7%
62/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Weight decreased
|
11.7%
50/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.2%
39/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.6%
45/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
7.3%
31/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood bilirubin increased
|
10.6%
45/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.3%
18/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.9%
42/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.8%
16/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.6%
28/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
4.0%
17/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.2%
22/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
2.1%
9/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.7%
118/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
19.9%
84/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.3%
48/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
9.9%
42/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.3%
31/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
7.6%
32/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.4%
40/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
3.1%
13/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
22/426 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
5.0%
21/423 • Day 1 up to 58 months
The Safety population consisted of all participants who received any amount of study treatment. Data for All-Cause Mortality were collected for the safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place