Trial Outcomes & Findings for A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (NCT NCT03143153)
NCT ID: NCT03143153
Last Updated: 2025-02-25
Results Overview
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
970 participants
Primary outcome timeframe
From the date of randomization to up to the date of death (up to approximately 20 months)
Results posted on
2025-02-25
Participant Flow
970 participants randomized, 936 treated.
Participant milestones
| Measure |
Arm A: Nivolumab + Ipilimumab
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Pre-Treatment
STARTED
|
325
|
321
|
324
|
|
Pre-Treatment
COMPLETED
|
322
|
310
|
304
|
|
Pre-Treatment
NOT COMPLETED
|
3
|
11
|
20
|
|
Treatment
STARTED
|
322
|
310
|
304
|
|
Treatment
COMPLETED
|
21
|
25
|
4
|
|
Treatment
NOT COMPLETED
|
301
|
285
|
300
|
Reasons for withdrawal
| Measure |
Arm A: Nivolumab + Ipilimumab
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Pre-Treatment
Participant request to discontinue study treatment
|
0
|
0
|
2
|
|
Pre-Treatment
Participant withdrew consent
|
0
|
1
|
12
|
|
Pre-Treatment
Participant no longer meets study criteria
|
0
|
4
|
2
|
|
Pre-Treatment
Other Reasons
|
1
|
2
|
1
|
|
Pre-Treatment
Disease Progression
|
1
|
1
|
2
|
|
Pre-Treatment
Adverse event unrelated to study drug
|
1
|
3
|
1
|
|
Treatment
Disease progression
|
174
|
184
|
193
|
|
Treatment
Study drug toxicity
|
59
|
33
|
40
|
|
Treatment
Death
|
5
|
3
|
4
|
|
Treatment
Adverse event unrelated to study drug
|
19
|
28
|
12
|
|
Treatment
Participant request to discontinue study treatment
|
13
|
15
|
20
|
|
Treatment
Participant withdrew consent
|
3
|
4
|
12
|
|
Treatment
Pregnancy
|
1
|
0
|
0
|
|
Treatment
Maximum clinical benefit
|
1
|
3
|
4
|
|
Treatment
Completed treatment as per Protocol
|
13
|
8
|
0
|
|
Treatment
Other reasons
|
12
|
7
|
15
|
|
Treatment
Not reported
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Baseline characteristics by cohort
| Measure |
Arm A: Nivolumab + Ipilimumab
n=325 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=321 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=324 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Total
n=970 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
63.3 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
269 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
797 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
79 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
248 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
71 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
131 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
394 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian Other
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to up to the date of death (up to approximately 20 months)Population: All randomized PD-L1 expressing participants
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=158 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=158 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=157 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Overall Survival (OS) in Participants With Tumor Cell PD-L1
|
13.70 Months
Interval 11.24 to 17.02
|
15.44 Months
Interval 11.93 to 19.52
|
9.07 Months
Interval 7.69 to 9.95
|
PRIMARY outcome
Timeframe: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)Population: All randomized PD-L1 expressing participants
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=158 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=158 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=157 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1
|
4.04 Months
Interval 2.4 to 4.93
|
6.93 Months
Interval 5.68 to 8.34
|
4.44 Months
Interval 2.89 to 5.82
|
SECONDARY outcome
Timeframe: From the date of randomization to up to the date of death (up to approximately 16 months)Population: All randomized participants
Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=325 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=321 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=324 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Overall Survival (OS) in All Randomized Participants
|
12.75 Months
Interval 11.27 to 15.47
|
13.21 Months
Interval 11.14 to 15.7
|
10.71 Months
Interval 9.4 to 11.93
|
SECONDARY outcome
Timeframe: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 7 months)Population: All randomized participants
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=325 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=321 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=324 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR
|
2.92 Months
Interval 2.66 to 4.17
|
5.82 Months
Interval 5.55 to 7.0
|
5.59 Months
Interval 4.27 to 5.88
|
SECONDARY outcome
Timeframe: From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months)Population: All randomized PD-L1 expressing participants and all randomized participants
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.
Outcome measures
| Measure |
Arm A: Nivolumab + Ipilimumab
n=325 Participants
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Arm B: Nivolumab + Chemotherapy
n=321 Participants
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Arm C: Chemotherapy
n=324 Participants
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status < 1%
|
20.1 Percentage of participants
Interval 14.3 to 27.1
|
41.7 Percentage of participants
Interval 34.1 to 49.7
|
33.7 Percentage of participants
Interval 26.6 to 41.5
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status >= 1%
|
35.4 Percentage of participants
Interval 28.0 to 43.4
|
53.2 Percentage of participants
Interval 45.1 to 61.1
|
19.9 Percentage of participants
Interval 13.9 to 27.0
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status < 5%
|
22.3 Percentage of participants
Interval 16.7 to 28.6
|
44.8 Percentage of participants
Interval 37.8 to 51.9
|
30.9 Percentage of participants
Interval 24.7 to 37.7
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status >= 5%
|
36.7 Percentage of participants
Interval 28.1 to 45.9
|
51.7 Percentage of participants
Interval 42.4 to 60.9
|
20.0 Percentage of participants
Interval 13.1 to 28.5
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status < 10%
|
23.3 Percentage of participants
Interval 17.9 to 29.5
|
46.1 Percentage of participants
Interval 39.4 to 53.0
|
29.3 Percentage of participants
Interval 23.5 to 35.8
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status >= 10%
|
36.9 Percentage of participants
Interval 27.6 to 47.0
|
50.0 Percentage of participants
Interval 39.9 to 60.1
|
21.6 Percentage of participants
Interval 13.9 to 31.2
|
|
Objective Response Rate (ORR) as Assessed by BICR
Participants with baseline PD-L1 status indeterminate, not evaluable, or missing
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
0.0 Percentage of participants
Interval 0.0 to 84.2
|
|
Objective Response Rate (ORR) as Assessed by BICR
All randomized participants
|
27.7 Percentage of participants
Interval 22.9 to 32.9
|
47.4 Percentage of participants
Interval 41.8 to 53.0
|
26.9 Percentage of participants
Interval 22.1 to 32.0
|
Adverse Events
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Serious events: 237 serious events
Other events: 301 other events
Deaths: 215 deaths
Nivolumab 240 mg + Chemotherapy
Serious events: 217 serious events
Other events: 307 other events
Deaths: 200 deaths
Chemotherapy
Serious events: 172 serious events
Other events: 288 other events
Deaths: 224 deaths
Serious adverse events
| Measure |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=322 participants at risk
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Nivolumab 240 mg + Chemotherapy
n=310 participants at risk
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Chemotherapy
n=304 participants at risk
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
2.0%
6/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
1.9%
6/310 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Angina pectoris
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Pericardial effusion
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Adrenal insufficiency
|
2.5%
8/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Endocrine disorder
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hypophysitis
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hypopituitarism
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hypothyroidism
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Thyroiditis
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Eye disorders
Cataract
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Eye disorders
Eye pain
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Eye disorders
Uveitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Eye disorders
Vogt-Koyanagi-Harada disease
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.97%
3/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Aorto-oesophageal fistula
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Colitis
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Constipation
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
1.9%
6/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
6.5%
20/310 • From first dose to 100 days post last dose, up to 43 months
|
5.3%
16/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Enteritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Gastric fistula
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Nausea
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal mass
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.97%
3/310 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
2.9%
9/310 • From first dose to 100 days post last dose, up to 43 months
|
4.3%
13/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophageal-pulmonary fistula
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Oesophagomediastinal fistula
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
3.9%
12/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Asthenia
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Catheter site discharge
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Chest pain
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Complication associated with device
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Death
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Disease progression
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Fatigue
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.97%
3/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Feeling cold
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
General physical health deterioration
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Malaise
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Nodule
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Non-cardiac chest pain
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Oedema peripheral
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Pain
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Performance status decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Polyp
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Pyrexia
|
4.3%
14/322 • From first dose to 100 days post last dose, up to 43 months
|
2.3%
7/310 • From first dose to 100 days post last dose, up to 43 months
|
2.3%
7/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Sudden death
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.8%
9/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Appendicitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Bacteraemia
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Bacterial infection
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Cystitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Encephalitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Lung abscess
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Meningitis viral
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Oral infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Otitis media
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Parotitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pneumonia
|
9.6%
31/322 • From first dose to 100 days post last dose, up to 43 months
|
10.6%
33/310 • From first dose to 100 days post last dose, up to 43 months
|
6.6%
20/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Postoperative wound infection
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pulmonary sepsis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Sepsis
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
0.97%
3/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Septic shock
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Stoma site cellulitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Urethritis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Urosepsis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Vascular device infection
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Viral infection
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Atrio-oesophageal fistula
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Overdose
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Stoma site extravasation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Adjusted calcium increased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Alanine aminotransferase increased
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood calcium increased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood creatinine increased
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood sodium decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Cortisol decreased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Electrocardiogram Q wave abnormal
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Lipase increased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Liver function test increased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Neutrophil count decreased
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Transaminases increased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Urine output decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
9/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
2.3%
7/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
8/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
2.0%
6/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Fulminant type 1 diabetes mellitus
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/310 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult T-cell lymphoma/leukaemia
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
18.3%
59/322 • From first dose to 100 days post last dose, up to 43 months
|
18.1%
56/310 • From first dose to 100 days post last dose, up to 43 months
|
20.4%
62/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone marrow
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Cerebral infarction
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Immune-mediated encephalopathy
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Presyncope
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Seizure
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Stupor
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Subdural hygroma
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Product Issues
Device breakage
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Product Issues
Device dislocation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Product Issues
Device leakage
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Product Issues
Device occlusion
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Product Issues
Patient-device incompatibility
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Assisted suicide
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Delirium
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Disorientation
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Pressure of speech
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
2.9%
9/310 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
4/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
2.6%
8/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
13/322 • From first dose to 100 days post last dose, up to 43 months
|
1.9%
6/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.65%
2/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.93%
3/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Surgical and medical procedures
Jejunostomy
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Surgical and medical procedures
Oesophageal operation
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Embolism
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypotension
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Internal haemorrhage
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Poor venous access
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Shock
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.66%
2/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Shock haemorrhagic
|
0.31%
1/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.32%
1/310 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
0.00%
0/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
Other adverse events
| Measure |
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=322 participants at risk
Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
|
Nivolumab 240 mg + Chemotherapy
n=310 participants at risk
Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
Chemotherapy
n=304 participants at risk
Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
82/322 • From first dose to 100 days post last dose, up to 43 months
|
48.7%
151/310 • From first dose to 100 days post last dose, up to 43 months
|
35.2%
107/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
11.6%
36/310 • From first dose to 100 days post last dose, up to 43 months
|
7.6%
23/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
20/322 • From first dose to 100 days post last dose, up to 43 months
|
2.3%
7/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Endocrine disorders
Hypothyroidism
|
13.7%
44/322 • From first dose to 100 days post last dose, up to 43 months
|
6.8%
21/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
22/322 • From first dose to 100 days post last dose, up to 43 months
|
7.1%
22/310 • From first dose to 100 days post last dose, up to 43 months
|
5.9%
18/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
16/322 • From first dose to 100 days post last dose, up to 43 months
|
6.5%
20/310 • From first dose to 100 days post last dose, up to 43 months
|
4.3%
13/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Constipation
|
25.8%
83/322 • From first dose to 100 days post last dose, up to 43 months
|
45.2%
140/310 • From first dose to 100 days post last dose, up to 43 months
|
45.1%
137/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Diarrhoea
|
26.1%
84/322 • From first dose to 100 days post last dose, up to 43 months
|
31.0%
96/310 • From first dose to 100 days post last dose, up to 43 months
|
20.7%
63/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Dysphagia
|
10.9%
35/322 • From first dose to 100 days post last dose, up to 43 months
|
12.6%
39/310 • From first dose to 100 days post last dose, up to 43 months
|
9.9%
30/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Nausea
|
27.0%
87/322 • From first dose to 100 days post last dose, up to 43 months
|
65.8%
204/310 • From first dose to 100 days post last dose, up to 43 months
|
56.6%
172/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Stomatitis
|
10.2%
33/322 • From first dose to 100 days post last dose, up to 43 months
|
31.9%
99/310 • From first dose to 100 days post last dose, up to 43 months
|
24.7%
75/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
52/322 • From first dose to 100 days post last dose, up to 43 months
|
23.9%
74/310 • From first dose to 100 days post last dose, up to 43 months
|
19.7%
60/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Asthenia
|
7.5%
24/322 • From first dose to 100 days post last dose, up to 43 months
|
7.1%
22/310 • From first dose to 100 days post last dose, up to 43 months
|
8.6%
26/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Fatigue
|
16.5%
53/322 • From first dose to 100 days post last dose, up to 43 months
|
26.5%
82/310 • From first dose to 100 days post last dose, up to 43 months
|
20.7%
63/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Infusion site extravasation
|
1.9%
6/322 • From first dose to 100 days post last dose, up to 43 months
|
4.8%
15/310 • From first dose to 100 days post last dose, up to 43 months
|
6.9%
21/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Malaise
|
8.1%
26/322 • From first dose to 100 days post last dose, up to 43 months
|
18.7%
58/310 • From first dose to 100 days post last dose, up to 43 months
|
18.1%
55/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Mucosal inflammation
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
11.6%
36/310 • From first dose to 100 days post last dose, up to 43 months
|
9.9%
30/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Oedema peripheral
|
9.6%
31/322 • From first dose to 100 days post last dose, up to 43 months
|
14.5%
45/310 • From first dose to 100 days post last dose, up to 43 months
|
8.2%
25/304 • From first dose to 100 days post last dose, up to 43 months
|
|
General disorders
Pyrexia
|
23.6%
76/322 • From first dose to 100 days post last dose, up to 43 months
|
20.0%
62/310 • From first dose to 100 days post last dose, up to 43 months
|
15.8%
48/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.3%
17/322 • From first dose to 100 days post last dose, up to 43 months
|
0.97%
3/310 • From first dose to 100 days post last dose, up to 43 months
|
0.33%
1/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Infections and infestations
Pneumonia
|
10.9%
35/322 • From first dose to 100 days post last dose, up to 43 months
|
10.0%
31/310 • From first dose to 100 days post last dose, up to 43 months
|
9.5%
29/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
45/322 • From first dose to 100 days post last dose, up to 43 months
|
8.4%
26/310 • From first dose to 100 days post last dose, up to 43 months
|
4.3%
13/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.6%
47/322 • From first dose to 100 days post last dose, up to 43 months
|
9.0%
28/310 • From first dose to 100 days post last dose, up to 43 months
|
3.9%
12/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
19/322 • From first dose to 100 days post last dose, up to 43 months
|
7.1%
22/310 • From first dose to 100 days post last dose, up to 43 months
|
3.3%
10/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Blood creatinine increased
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
13.5%
42/310 • From first dose to 100 days post last dose, up to 43 months
|
12.8%
39/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/322 • From first dose to 100 days post last dose, up to 43 months
|
6.5%
20/310 • From first dose to 100 days post last dose, up to 43 months
|
3.0%
9/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Lymphocyte count decreased
|
2.5%
8/322 • From first dose to 100 days post last dose, up to 43 months
|
5.2%
16/310 • From first dose to 100 days post last dose, up to 43 months
|
3.0%
9/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Neutrophil count decreased
|
3.1%
10/322 • From first dose to 100 days post last dose, up to 43 months
|
24.2%
75/310 • From first dose to 100 days post last dose, up to 43 months
|
20.1%
61/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Platelet count decreased
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
14.8%
46/310 • From first dose to 100 days post last dose, up to 43 months
|
11.8%
36/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Weight decreased
|
12.7%
41/322 • From first dose to 100 days post last dose, up to 43 months
|
12.9%
40/310 • From first dose to 100 days post last dose, up to 43 months
|
11.5%
35/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
Weight increased
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
7.4%
23/310 • From first dose to 100 days post last dose, up to 43 months
|
4.6%
14/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Investigations
White blood cell count decreased
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
18.7%
58/310 • From first dose to 100 days post last dose, up to 43 months
|
13.5%
41/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
69/322 • From first dose to 100 days post last dose, up to 43 months
|
51.6%
160/310 • From first dose to 100 days post last dose, up to 43 months
|
51.0%
155/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
6.5%
20/310 • From first dose to 100 days post last dose, up to 43 months
|
3.0%
9/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
6.5%
20/310 • From first dose to 100 days post last dose, up to 43 months
|
7.2%
22/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.6%
34/322 • From first dose to 100 days post last dose, up to 43 months
|
8.1%
25/310 • From first dose to 100 days post last dose, up to 43 months
|
6.6%
20/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.2%
7/322 • From first dose to 100 days post last dose, up to 43 months
|
5.5%
17/310 • From first dose to 100 days post last dose, up to 43 months
|
1.6%
5/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.9%
32/322 • From first dose to 100 days post last dose, up to 43 months
|
14.2%
44/310 • From first dose to 100 days post last dose, up to 43 months
|
9.9%
30/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.6%
31/322 • From first dose to 100 days post last dose, up to 43 months
|
17.4%
54/310 • From first dose to 100 days post last dose, up to 43 months
|
11.8%
36/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
13/322 • From first dose to 100 days post last dose, up to 43 months
|
5.5%
17/310 • From first dose to 100 days post last dose, up to 43 months
|
1.3%
4/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
24/322 • From first dose to 100 days post last dose, up to 43 months
|
5.8%
18/310 • From first dose to 100 days post last dose, up to 43 months
|
4.6%
14/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
20/322 • From first dose to 100 days post last dose, up to 43 months
|
3.2%
10/310 • From first dose to 100 days post last dose, up to 43 months
|
5.3%
16/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.6%
18/322 • From first dose to 100 days post last dose, up to 43 months
|
4.5%
14/310 • From first dose to 100 days post last dose, up to 43 months
|
6.2%
19/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Dizziness
|
4.7%
15/322 • From first dose to 100 days post last dose, up to 43 months
|
5.5%
17/310 • From first dose to 100 days post last dose, up to 43 months
|
9.5%
29/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Dysgeusia
|
3.1%
10/322 • From first dose to 100 days post last dose, up to 43 months
|
7.4%
23/310 • From first dose to 100 days post last dose, up to 43 months
|
6.2%
19/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Headache
|
8.1%
26/322 • From first dose to 100 days post last dose, up to 43 months
|
8.7%
27/310 • From first dose to 100 days post last dose, up to 43 months
|
5.3%
16/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
7.1%
22/310 • From first dose to 100 days post last dose, up to 43 months
|
4.9%
15/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
5/322 • From first dose to 100 days post last dose, up to 43 months
|
10.0%
31/310 • From first dose to 100 days post last dose, up to 43 months
|
9.2%
28/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Psychiatric disorders
Insomnia
|
9.9%
32/322 • From first dose to 100 days post last dose, up to 43 months
|
17.4%
54/310 • From first dose to 100 days post last dose, up to 43 months
|
13.2%
40/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Renal and urinary disorders
Renal impairment
|
0.62%
2/322 • From first dose to 100 days post last dose, up to 43 months
|
3.5%
11/310 • From first dose to 100 days post last dose, up to 43 months
|
5.6%
17/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.4%
40/322 • From first dose to 100 days post last dose, up to 43 months
|
13.9%
43/310 • From first dose to 100 days post last dose, up to 43 months
|
12.2%
37/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
23/322 • From first dose to 100 days post last dose, up to 43 months
|
4.2%
13/310 • From first dose to 100 days post last dose, up to 43 months
|
3.6%
11/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
12/322 • From first dose to 100 days post last dose, up to 43 months
|
17.1%
53/310 • From first dose to 100 days post last dose, up to 43 months
|
20.7%
63/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
16/322 • From first dose to 100 days post last dose, up to 43 months
|
6.1%
19/310 • From first dose to 100 days post last dose, up to 43 months
|
2.0%
6/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
9/322 • From first dose to 100 days post last dose, up to 43 months
|
13.5%
42/310 • From first dose to 100 days post last dose, up to 43 months
|
13.8%
42/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
17/322 • From first dose to 100 days post last dose, up to 43 months
|
4.2%
13/310 • From first dose to 100 days post last dose, up to 43 months
|
3.9%
12/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
59/322 • From first dose to 100 days post last dose, up to 43 months
|
11.9%
37/310 • From first dose to 100 days post last dose, up to 43 months
|
6.2%
19/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.0%
74/322 • From first dose to 100 days post last dose, up to 43 months
|
13.5%
42/310 • From first dose to 100 days post last dose, up to 43 months
|
6.9%
21/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
18/322 • From first dose to 100 days post last dose, up to 43 months
|
2.6%
8/310 • From first dose to 100 days post last dose, up to 43 months
|
0.99%
3/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypertension
|
2.8%
9/322 • From first dose to 100 days post last dose, up to 43 months
|
7.7%
24/310 • From first dose to 100 days post last dose, up to 43 months
|
7.2%
22/304 • From first dose to 100 days post last dose, up to 43 months
|
|
Vascular disorders
Hypotension
|
3.4%
11/322 • From first dose to 100 days post last dose, up to 43 months
|
4.2%
13/310 • From first dose to 100 days post last dose, up to 43 months
|
5.3%
16/304 • From first dose to 100 days post last dose, up to 43 months
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER