Trial Outcomes & Findings for Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) (NCT NCT02231749)
NCT ID: NCT02231749
Last Updated: 2025-06-26
Results Overview
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1390 participants
Primary outcome timeframe
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
Results posted on
2025-06-26
Participant Flow
A total 1390 patients were enrolled in the study. Of these, 1096 were randomized. Of those randomized, 1082 received treatment (547 with Nivo+Ipi and 535 with Sunitinib). 240 patients who were not randomized because they no longer met study criteria, 24 withdrew consent, 4 for Adverse Events, 4 for Death, 4 for Poor Compliance, and 18 other.
Participant milestones
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
550
|
546
|
|
Overall Study
Received Treatment
|
547
|
535
|
|
Overall Study
COMPLETED
|
128
|
97
|
|
Overall Study
NOT COMPLETED
|
422
|
449
|
Reasons for withdrawal
| Measure |
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Study
Disease progression
|
229
|
297
|
|
Overall Study
Study Drug Toxicity
|
134
|
63
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
AE unrelated to Study drug
|
32
|
31
|
|
Overall Study
Participant's request to discontinue
|
10
|
21
|
|
Overall Study
Participant withdrew Consent
|
8
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Maximum Clinical Benefit
|
5
|
8
|
|
Overall Study
Poor/Non-Compliance
|
0
|
3
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
other
|
0
|
8
|
|
Overall Study
No longer meets Study Criteria
|
1
|
0
|
Baseline Characteristics
All Randomized
Baseline characteristics by cohort
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
Total
n=1096 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 9.76 • n=5 Participants • All Randomized
|
60.7 Years
STANDARD_DEVIATION 10.10 • n=7 Participants • All Randomized
|
60.9 Years
STANDARD_DEVIATION 9.93 • n=5 Participants • All Randomized
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants • All Randomized Participants
|
151 Participants
n=7 Participants • All Randomized Participants
|
288 Participants
n=5 Participants • All Randomized Participants
|
|
Sex: Female, Male
Male
|
413 Participants
n=5 Participants • All Randomized Participants
|
395 Participants
n=7 Participants • All Randomized Participants
|
808 Participants
n=5 Participants • All Randomized Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
517 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
274 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
486 Participants
n=5 Participants • All Randomized Participants
|
483 Participants
n=7 Participants • All Randomized Participants
|
969 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants • All Randomized Participants
|
6 Participants
n=7 Participants • All Randomized Participants
|
13 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Asian
|
46 Participants
n=5 Participants • All Randomized Participants
|
47 Participants
n=7 Participants • All Randomized Participants
|
93 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants • All Randomized Participants
|
10 Participants
n=7 Participants • All Randomized Participants
|
20 Participants
n=5 Participants • All Randomized Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
1 Participants
n=5 Participants • All Randomized Participants
|
PRIMARY outcome
Timeframe: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1
|
41.6 percentage of participants
Interval 36.9 to 46.5
|
26.5 percentage of participants
Interval 22.4 to 31.0
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
NA months
Interval 28.16 to
The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
|
25.95 months
Interval 22.08 to
The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Intermediate/Poor-Risk Participants
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=425 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=422 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
11.56 months
Interval 8.71 to 15.51
|
8.38 months
Interval 7.03 to 10.81
|
SECONDARY outcome
Timeframe: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Randomized
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
|
38.7 percentage of participants
Interval 34.6 to 42.9
|
32.2 percentage of participants
Interval 28.3 to 36.3
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)Population: All Randomized
Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
NA months
The median for Overall Survival, Lower limit, and Upper Limit have not been reached. There were an insufficient number of participants with events.
|
32.92 months
The Lower Limit and Upper Limit have not been reached. With only 1 participant at that time point, the variance is not estimable and so the Confidence Intervals were N/A.
|
SECONDARY outcome
Timeframe: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)Population: All Randomized
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
Outcome measures
| Measure |
Nivolumab + Ipilimumab
n=550 Participants
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=546 Participants
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
|
12.42 months
Interval 9.89 to 16.53
|
12.32 months
Interval 9.79 to 15.24
|
Adverse Events
Nivolumab + Ipilimumab
Serious events: 305 serious events
Other events: 530 other events
Deaths: 159 deaths
Sunitinib
Serious events: 213 serious events
Other events: 522 other events
Deaths: 202 deaths
Serious adverse events
| Measure |
Nivolumab + Ipilimumab
n=547 participants at risk
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=535 participants at risk
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.3%
7/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Autoimmune neutropenia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Angina pectoris
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Arrhythmia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardiac failure
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Cardiovascular disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Myocarditis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
1.8%
10/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Basedow's disease
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Goitre
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hypophysitis
|
2.6%
14/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hypopituitarism
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Thyroiditis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Eye disorders
Diplopia
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Eye disorders
Eye pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Eye disorders
Inflammation of lacrimal passage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Colitis
|
1.8%
10/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
24/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Ileus
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Nausea
|
1.5%
8/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Asthenia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Chest discomfort
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Chest pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Death
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Fatigue
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.93%
5/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
General physical health deterioration
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Influenza like illness
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Malaise
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Oedema peripheral
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Pain
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Pyrexia
|
3.3%
18/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.7%
9/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Sudden death
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Immune system disorders
Autoimmune disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Immune system disorders
Contrast media allergy
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Immune system disorders
Contrast media reaction
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Appendicitis
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Bronchitis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Cellulitis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Diarrhoea infectious
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Diverticulitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Encephalitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Epididymitis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Gastroenteritis
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Herpes zoster disseminated
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Infection
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Influenza
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Laryngitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Lung abscess
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Lung infection
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Meningitis aseptic
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Pneumonia
|
3.1%
17/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.5%
8/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Pulmonary sepsis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Sepsis
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.1%
6/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Septic shock
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Soft tissue infection
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Urosepsis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Viral infection
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Wound
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood creatinine increased
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood potassium increased
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Lipase increased
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Pancreatic enzymes increased
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Transaminases increased
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Troponin increased
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
7/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.5%
8/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Fulminant type 1 diabetes mellitus
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.93%
5/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.75%
4/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.0%
22/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.8%
31/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Aphasia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Brain oedema
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Central nervous system lesion
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Facial nerve disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Facial paralysis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Facial paresis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Headache
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Iiird nerve paralysis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Intracranial pressure increased
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Ischaemic stroke
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Myasthenia gravis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Paraesthesia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Paraparesis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Polyneuropathy
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Seizure
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Speech disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Syncope
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Thecal sac compression
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Product Issues
Device breakage
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Confusional state
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Delirium
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Suicide attempt
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
8/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.5%
8/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Haematuria
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.5%
8/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Micturition urgency
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Nephritis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Polyuria
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Renal failure
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Renal impairment
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Renal injury
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.7%
9/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
7/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.7%
9/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.7%
15/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Stevens-johnson syndrome
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Social circumstances
Immobile
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Angiopathy
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Embolism
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Haematoma
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.19%
1/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.56%
3/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Hypotension
|
0.73%
4/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.37%
2/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Shock
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Subclavian vein occlusion
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Vein rupture
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Venous thrombosis
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
0.00%
0/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
Other adverse events
| Measure |
Nivolumab + Ipilimumab
n=547 participants at risk
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
|
Sunitinib
n=535 participants at risk
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
71/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
20.2%
108/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.18%
1/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.8%
31/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
13.6%
73/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
18.3%
98/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hyperthyroidism
|
11.5%
63/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
3.0%
16/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Endocrine disorders
Hypothyroidism
|
17.2%
94/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
26.9%
144/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Eye disorders
Vision blurred
|
5.1%
28/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
1.9%
10/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
14/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
12.6%
69/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
14.2%
76/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
26/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
8.2%
44/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Constipation
|
17.0%
93/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
17.6%
94/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
36.2%
198/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
57.9%
310/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Dry mouth
|
6.4%
35/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.9%
37/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
29/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
20.9%
112/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
7/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.8%
31/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
11/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
12.5%
67/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.2%
12/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Nausea
|
29.4%
161/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
43.0%
230/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Oral pain
|
0.37%
2/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.6%
30/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
29/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
28.4%
152/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Toothache
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
108/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
27.7%
148/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Asthenia
|
16.1%
88/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
18.5%
99/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Chest pain
|
4.2%
23/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Chills
|
5.7%
31/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.9%
42/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Fatigue
|
45.0%
246/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
54.4%
291/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Influenza like illness
|
8.4%
46/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Malaise
|
2.2%
12/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.2%
28/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Mucosal inflammation
|
3.3%
18/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
29.2%
156/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Oedema peripheral
|
13.7%
75/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
12.3%
66/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Pain
|
6.0%
33/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
8.4%
45/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
General disorders
Pyrexia
|
23.0%
126/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
15.9%
85/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
34/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.5%
35/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Urinary tract infection
|
5.3%
29/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
4.5%
24/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.4%
46/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
3.9%
21/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Alanine aminotransferase increased
|
11.5%
63/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
11.2%
60/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Amylase increased
|
13.9%
76/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.9%
42/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Aspartate aminotransferase increased
|
12.6%
69/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
10.7%
57/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
32/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
4.5%
24/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood creatinine increased
|
11.9%
65/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
9.2%
49/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.2%
12/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.0%
32/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Lipase increased
|
17.6%
96/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
12.1%
65/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Neutrophil count decreased
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.5%
40/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Platelet count decreased
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
14.2%
76/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
Weight decreased
|
8.6%
47/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.7%
41/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Investigations
White blood cell count decreased
|
1.1%
6/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.7%
41/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.8%
114/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
29.2%
156/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
28/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
4.1%
22/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.9%
54/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
4.3%
23/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.6%
36/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
3.9%
21/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
17/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.0%
32/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.0%
33/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.2%
28/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.3%
122/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
15.5%
83/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
87/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
16.6%
89/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
34/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.2%
28/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
36/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.2%
33/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.7%
64/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.4%
34/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.3%
62/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
14.2%
76/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Dizziness
|
11.2%
61/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
11.4%
61/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Dysgeusia
|
7.3%
40/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
34.6%
185/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Headache
|
18.6%
102/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
22.4%
120/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Nervous system disorders
Paraesthesia
|
6.0%
33/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.4%
29/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Anxiety
|
5.3%
29/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
3.9%
21/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Psychiatric disorders
Insomnia
|
10.6%
58/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.5%
35/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
144/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
23.4%
125/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
18/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.2%
28/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
95/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
17.2%
92/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
7/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
14.0%
75/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
26/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
7.5%
40/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.91%
5/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.1%
55/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
9.9%
53/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
6.0%
32/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.6%
9/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
44.3%
237/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.9%
180/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
10.8%
58/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.4%
139/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
15.7%
84/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.1%
55/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.2%
28/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.55%
3/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
5.0%
27/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
8.4%
45/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
|
Vascular disorders
Hypertension
|
9.5%
52/547 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)
|
43.0%
230/535 • From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 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