Trial Outcomes & Findings for A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (NCT NCT03215706)
NCT ID: NCT03215706
Last Updated: 2024-12-24
Results Overview
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
719 participants
Primary outcome timeframe
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Results posted on
2024-12-24
Participant Flow
719 Randomized; 707 Treated; reasons not treated: 1 adverse event unrelated to the study drug, 4 participants withdrew consent, 5 no longer meet study criteria and 2 other reasons.
Participant milestones
| Measure |
Treatment A
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
Chemotherapy only
|
|---|---|---|
|
Randomization
STARTED
|
361
|
358
|
|
Randomization
COMPLETED
|
358
|
349
|
|
Randomization
NOT COMPLETED
|
3
|
9
|
|
Treatment Period
STARTED
|
358
|
349
|
|
Treatment Period
COMPLETED
|
16
|
103
|
|
Treatment Period
NOT COMPLETED
|
342
|
246
|
Reasons for withdrawal
| Measure |
Treatment A
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
Chemotherapy only
|
|---|---|---|
|
Randomization
Adverse Event unrelated to study drug
|
1
|
0
|
|
Randomization
participant withdrew consent
|
1
|
3
|
|
Randomization
no longer meets study criteria
|
1
|
4
|
|
Randomization
other reasons
|
0
|
2
|
|
Treatment Period
Disease Progression
|
150
|
142
|
|
Treatment Period
Study Drug Toxicity
|
53
|
21
|
|
Treatment Period
Death
|
2
|
1
|
|
Treatment Period
Adverse event unrelated to study drug
|
24
|
23
|
|
Treatment Period
Request to D/C treatment
|
1
|
6
|
|
Treatment Period
Participant withdrew consent
|
3
|
4
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Treatment Period
Other Reasons
|
4
|
5
|
|
Treatment Period
Ongoing in the treatment period
|
105
|
43
|
Baseline Characteristics
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Baseline characteristics by cohort
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
Total
n=719 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.0 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
65.0 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Customized
˂65 years old
|
176 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Age, Customized
≥65 and ˂75 years old
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Age, Customized
≥75 years old
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Customized
≥85 years old
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
178 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
322 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
638 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
Overall Survival (OS)
|
14.13 Months
Interval 13.24 to 16.16
|
10.74 Months
Interval 9.46 to 12.45
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
Progression Free Survival (PFS) by BICR
|
6.83 Months
Interval 5.55 to 7.66
|
4.96 Months
Interval 4.27 to 5.55
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
Objective Response Rate (ORR) by BICR
|
37.7 Percentage of Participants
Interval 32.7 to 42.9
|
25.1 Percentage of Participants
Interval 20.7 to 30.0
|
SECONDARY outcome
Timeframe: From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)Population: All confirmed Responders, Global Population
DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
Outcome measures
| Measure |
Treatment A
n=136 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=90 Participants
Chemotherapy only
|
|---|---|---|
|
Duration of Response (DoR)
|
10.02 Months
Interval 8.21 to 13.01
|
5.09 Months
Interval 4.34 to 7.0
|
SECONDARY outcome
Timeframe: From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)Population: All Confirmed Responders, Global Population
TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.
Outcome measures
| Measure |
Treatment A
n=136 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=90 Participants
Chemotherapy only
|
|---|---|---|
|
Time to Response (TTR)
|
2.51 Months
Interval 1.1 to 10.6
|
1.56 Months
Interval 1.2 to 8.3
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
PD-L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC 28-8 pharmDx test. PD-L1 expression was classified as PD-L1 ≥1% (≥1% tumor cells with membrane staining in a minimum of a hundred evaluable tumor cells), PD-L1 \< 1% and PD-L1 not quantifiable (without quantifiable PD-L1 expression), PD-L1 expression ≥ 50%, PD-L1 expression 1 to 49%
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
BASELINE PD-L1 EXPRESSION ≥1%
|
41.9 Percentage of Participants
Interval 35.0 to 49.0
|
27.6 Percentage of Participants
Interval 21.6 to 34.3
|
|
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
BASELINE PD-L1 EXPRESSION < 1%
|
31.1 Percentage of Participants
Interval 23.4 to 39.6
|
20.9 Percentage of Participants
Interval 14.3 to 29.0
|
|
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Non-Quantifiable PD-L1 Expression
|
33.3 Percentage of Participants
Interval 14.6 to 57.0
|
28.0 Percentage of Participants
Interval 12.1 to 49.4
|
|
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
BASELINE PD-L1 EXPRESSION 1 - 49%
|
37.8 Percentage of Participants
Interval 29.3 to 46.8
|
24.5 Percentage of Participants
Interval 16.7 to 33.8
|
|
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
BASELINE PD-L1 EXPRESSION >= 50%
|
48.7 Percentage of Participants
Interval 37.0 to 60.4
|
30.9 Percentage of Participants
Interval 21.9 to 41.1
|
SECONDARY outcome
Timeframe: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
PFS by BICR by PD-L1 Tumor Cell Expression
with 1-49% PD-L1 Expression
|
6.74 Months
Interval 5.39 to 8.51
|
5.29 Months
Interval 4.24 to 5.68
|
|
PFS by BICR by PD-L1 Tumor Cell Expression
< 1% PD-L1 Expression
|
5.82 Months
Interval 4.4 to 7.26
|
4.86 Months
Interval 4.17 to 5.65
|
|
PFS by BICR by PD-L1 Tumor Cell Expression
>= 1% PD-L1 Expression
|
7.03 Months
Interval 5.55 to 8.51
|
4.70 Months
Interval 4.24 to 5.55
|
|
PFS by BICR by PD-L1 Tumor Cell Expression
with >= 50% PD-L1 Expression
|
8.28 Months
Interval 4.47 to 11.5
|
4.27 Months
Interval 4.14 to 5.45
|
|
PFS by BICR by PD-L1 Tumor Cell Expression
Non-Quantifiable PD-L1 Expression
|
6.14 Months
Interval 3.61 to 11.47
|
5.78 Months
Interval 2.83 to 8.84
|
SECONDARY outcome
Timeframe: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)Population: All Randomized Participants, Global Population
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Outcome measures
| Measure |
Treatment A
n=361 Participants
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=358 Participants
Chemotherapy only
|
|---|---|---|
|
OS by PD-L1 Tumor Cell Expression
< 1% PD-L1 Expression
|
14.03 Months
Interval 13.24 to
Upper Limit Not Reached
|
9.95 Months
Interval 7.69 to 13.73
|
|
OS by PD-L1 Tumor Cell Expression
>= 1% PD-L1 Expression
|
14.23 Months
Interval 13.08 to
Upper Limit Not Reached
|
10.58 Months
Interval 9.36 to 12.55
|
|
OS by PD-L1 Tumor Cell Expression
with 1-49% PD-L1 Expression
|
14.46 Months
Interval 12.45 to
Upper Limit Not Reached
|
10.25 Months
Interval 8.67 to 12.22
|
|
OS by PD-L1 Tumor Cell Expression
with >= 50% PD-L1 Expression
|
14.13 Months
Interval 12.39 to
Upper Limit Not Reached
|
11.86 Months
Interval 9.26 to
Upper Limit Not Reached
|
|
OS by PD-L1 Tumor Cell Expression
Non-Quantifiable PD-L1 Expression
|
10.84 Months
Interval 7.16 to 15.57
|
17.05 Months
Interval 8.64 to
Upper Limit Not Reached
|
Adverse Events
Treatment A
Serious events: 203 serious events
Other events: 336 other events
Deaths: 153 deaths
Treatment B
Serious events: 144 serious events
Other events: 322 other events
Deaths: 191 deaths
Serious adverse events
| Measure |
Treatment A
n=358 participants at risk
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=349 participants at risk
Chemotherapy only
|
|---|---|---|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Eye disorders
Cataract
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Colitis
|
1.4%
5/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
13/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Nausea
|
1.4%
5/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
6/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.1%
4/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Asthenia
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Death
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Fatigue
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
General physical health deterioration
|
1.4%
5/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Inflammation
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Influenza like illness
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Mucosal inflammation
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Oedema peripheral
|
1.1%
4/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Pain
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Polyserositis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Pyrexia
|
1.1%
4/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Sudden death
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Immune system disorders
Contrast media reaction
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Abdominal infection
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Appendicitis
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Bronchitis
|
1.7%
6/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Device related infection
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Empyema
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Infective spondylitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Localised infection
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Lung abscess
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Lung infection
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Osteomyelitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pneumonia
|
4.5%
16/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.6%
16/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pulmonary mycosis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pulmonary sepsis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Pyelonephritis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Respiratory tract infection
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Sepsis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Tuberculosis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Urethritis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Alanine aminotransferase increased
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Blood creatinine increased
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
C-reactive protein increased
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Haematocrit decreased
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Transaminases increased
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
5/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.1%
4/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
11/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.0%
14/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
11/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.6%
9/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
4/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.1%
4/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.4%
5/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.0%
7/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Cardiac failure
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Myocardial infarction
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Cardiac disorders
Ventricular dysfunction
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Ear and labyrinth disorders
Deafness
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Adrenal insufficiency
|
1.7%
6/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Endocrine disorder
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Hypophysitis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.8%
28/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
8.3%
29/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Agraphia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Brain oedema
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Dizziness
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Headache
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Motor dysfunction
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Nervous system disorder
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Paraesthesia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Seizure
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Psychiatric disorders
Confusional state
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
8/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.4%
5/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Renal failure
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
8/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.0%
7/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.84%
3/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
4/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
7/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.1%
4/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
4/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
7/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Embolism
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Thrombosis
|
0.56%
2/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.29%
1/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Vascular disorders
Venous thrombosis
|
0.28%
1/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.00%
0/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
Other adverse events
| Measure |
Treatment A
n=358 participants at risk
Nivolumab + Ipilimumab + Chemotherapy
|
Treatment B
n=349 participants at risk
Chemotherapy only
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
111/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
44.7%
156/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.5%
34/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
16.9%
59/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
18/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
9.7%
34/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Hyperthyroidism
|
8.1%
29/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.57%
2/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
55/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
3.2%
11/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
23/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
6.0%
21/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
18/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.3%
15/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Constipation
|
21.2%
76/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
22.3%
78/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Diarrhoea
|
27.4%
98/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
18.1%
63/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Nausea
|
31.0%
111/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
41.0%
143/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
60/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
16.9%
59/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Asthenia
|
28.5%
102/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
24.6%
86/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Fatigue
|
21.2%
76/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
15.8%
55/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Mucosal inflammation
|
5.3%
19/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.9%
10/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Oedema peripheral
|
6.7%
24/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
7.7%
27/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
General disorders
Pyrexia
|
12.8%
46/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
9.7%
34/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
27/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.9%
17/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Amylase increased
|
7.5%
27/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.6%
9/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
22/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
3.2%
11/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
19/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
5.2%
18/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Blood creatinine increased
|
5.9%
21/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
5.7%
20/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Lipase increased
|
7.5%
27/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.4%
5/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Investigations
Weight decreased
|
8.9%
32/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
6.0%
21/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.2%
101/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
21.5%
75/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
18/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.7%
6/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
24/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
6.9%
24/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
20/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
5.7%
20/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
22/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
6.9%
24/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.4%
30/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
5.2%
18/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
47/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
7.2%
25/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
43/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
8.6%
30/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.1%
29/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
3.7%
13/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
25/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
3.7%
13/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Dizziness
|
7.5%
27/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.6%
16/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Nervous system disorders
Headache
|
10.6%
38/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
7.2%
25/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Psychiatric disorders
Insomnia
|
6.1%
22/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
3.4%
12/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
55/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
11.2%
39/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.1%
54/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
11.5%
40/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
41/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
9.7%
34/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
19/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
0.86%
3/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.1%
72/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
2.3%
8/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.4%
66/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
4.0%
14/349 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
19/358 • 30 days after last dose, assessed up to October 2019, approximately 23 months
|
1.4%
5/349 • 30 days after last dose, assessed up to October 2019, approximately 23 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
- Publication restrictions are in place
Restriction type: LTE60