Trial Outcomes & Findings for Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone (NCT NCT01450761)
NCT ID: NCT01450761
Last Updated: 2020-07-08
Results Overview
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1351 participants
Primary outcome timeframe
Randomization until date of death, up to March 2015, approximately 38 months
Results posted on
2020-07-08
Participant Flow
Of the 1414 enrolled participants, 566 participants each were randomized to Ipilimumab and placebo arms. The remaining 282 participants were not randomized, the most frequently reported reason being that the participants no longer met study criteria.
Participant milestones
| Measure |
Ipilimumab and Platinum/Etoposide
During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
|---|---|---|
|
Randomization
STARTED
|
566
|
566
|
|
Randomization
COMPLETED
|
562
|
561
|
|
Randomization
NOT COMPLETED
|
4
|
5
|
|
Lead-in Chemotherapy
STARTED
|
562
|
561
|
|
Lead-in Chemotherapy
COMPLETED
|
478
|
476
|
|
Lead-in Chemotherapy
NOT COMPLETED
|
84
|
85
|
|
Treatment With Blinded Study Therapy
STARTED
|
478
|
476
|
|
Treatment With Blinded Study Therapy
COMPLETED
|
0
|
0
|
|
Treatment With Blinded Study Therapy
NOT COMPLETED
|
478
|
476
|
Reasons for withdrawal
| Measure |
Ipilimumab and Platinum/Etoposide
During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
|---|---|---|
|
Randomization
Subject no longer meets study criteria
|
1
|
2
|
|
Randomization
Withdrawal by Subject
|
2
|
0
|
|
Randomization
Disease progression
|
0
|
2
|
|
Randomization
Adverse Event unrelated to study drug
|
1
|
0
|
|
Randomization
Other
|
0
|
1
|
|
Lead-in Chemotherapy
Disease progression
|
33
|
32
|
|
Lead-in Chemotherapy
Adverse event unrelated to study drug
|
21
|
19
|
|
Lead-in Chemotherapy
Withdrawal by Subject
|
14
|
12
|
|
Lead-in Chemotherapy
Study drug toxicity
|
6
|
10
|
|
Lead-in Chemotherapy
No longer meets study criteria
|
3
|
7
|
|
Lead-in Chemotherapy
Death
|
3
|
3
|
|
Lead-in Chemotherapy
Other
|
2
|
2
|
|
Lead-in Chemotherapy
Lost to Follow-up
|
2
|
0
|
|
Treatment With Blinded Study Therapy
Disease progression
|
318
|
415
|
|
Treatment With Blinded Study Therapy
Study drug toxicity
|
87
|
9
|
|
Treatment With Blinded Study Therapy
Adverse event unrelated to study drug
|
27
|
19
|
|
Treatment With Blinded Study Therapy
Subject request to discontinue treatment
|
15
|
8
|
|
Treatment With Blinded Study Therapy
Withdrawal by Subject
|
12
|
5
|
|
Treatment With Blinded Study Therapy
Death
|
5
|
6
|
|
Treatment With Blinded Study Therapy
Other/Unspecified
|
5
|
4
|
|
Treatment With Blinded Study Therapy
Lost to Follow-up
|
2
|
1
|
|
Treatment With Blinded Study Therapy
Maximum clinical benefit
|
1
|
2
|
|
Treatment With Blinded Study Therapy
No longer meets study criteria
|
1
|
2
|
|
Treatment With Blinded Study Therapy
Not reported
|
2
|
2
|
|
Treatment With Blinded Study Therapy
Poor/non-compliance
|
1
|
0
|
|
Treatment With Blinded Study Therapy
Administrative reason by sponsor
|
2
|
3
|
Baseline Characteristics
Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
Baseline characteristics by cohort
| Measure |
Ipilimumab and Platinum/Etoposide
n=478 Participants
Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
n=476 Participants
Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
Total
n=954 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 8.90 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 8.61 • n=107 Participants
|
61.9 years
STANDARD_DEVIATION 8.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
317 Participants
n=99 Participants
|
326 Participants
n=107 Participants
|
643 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization until date of death, up to March 2015, approximately 38 monthsPopulation: All randomized participants who received at least one dose of blinded study therapy
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Ipilimumab and Platinum/Etoposide
n=478 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
n=476 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
|---|---|---|
|
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy
|
10.97 months
Interval 10.45 to 11.33
|
10.94 months
Interval 10.02 to 11.5
|
SECONDARY outcome
Timeframe: From randomization until date of death, up to March 2015, approximately 38 monthsPopulation: All randomized participants
Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Outcome measures
| Measure |
Ipilimumab and Platinum/Etoposide
n=566 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
n=566 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
|---|---|---|
|
Overall Survival in All Randomized Participants
|
10.22 months
Interval 9.59 to 10.81
|
9.95 months
Interval 9.33 to 10.94
|
SECONDARY outcome
Timeframe: From randomization until disease progression, up to March 2015, approximately 38 monthsPopulation: All randomized participants who received at least one dose of blinded study therapy
Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Outcome measures
| Measure |
Ipilimumab and Platinum/Etoposide
n=478 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
|
Placebo and Platinum/Etoposide
n=476 Participants
Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
|
|---|---|---|
|
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy
|
4.63 months
Interval 4.5 to 4.99
|
4.44 months
Interval 4.37 to 4.63
|
Adverse Events
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE
Serious events: 316 serious events
Other events: 519 other events
Deaths: 0 deaths
PLACEBO + PLATINUM/ETOPOSIDE
Serious events: 278 serious events
Other events: 520 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE
n=562 participants at risk
|
PLACEBO + PLATINUM/ETOPOSIDE
n=561 participants at risk
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiac arrest
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardio-respiratory distress
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Chest pain
|
0.89%
5/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Condition aggravated
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
General physical condition abnormal
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Hypotension
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.4%
36/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
7.7%
43/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.71%
4/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Seizure
|
0.89%
5/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.2%
7/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Thrombophlebitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Thrombosis
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Weight decreased
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Death
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
42/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.3%
13/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Embolic stroke
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Encephalitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Fatigue
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Haematemesis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
12/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.3%
13/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Ileus
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
9/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.71%
4/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Septic shock
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Sudden cardiac death
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Adrenalitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Blood creatinine increased
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiac failure
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Circulatory collapse
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Depression
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Enteritis
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Full blood count decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Hypophysitis
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Infection
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Influenza
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Lipase increased
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.4%
8/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Multi-organ failure
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.1%
6/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Myocardial infarction
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
1.6%
9/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.3%
13/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Sudden death
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
10/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.6%
9/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Euthanasia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Immune system disorders
Food allergy
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Renal and urinary disorders
Haematuria
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Hyperthyroidism
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Infectious pleural effusion
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Monoplegia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Nausea
|
2.1%
12/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Respiratory tract infection
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.1%
6/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Spinal cord compression
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Bronchopneumonia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Colitis
|
4.3%
24/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Disease progression
|
1.1%
6/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.6%
9/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
13/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.9%
16/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Embolism
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Headache
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Hypothyroidism
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Lung infection
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Myasthenic syndrome
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Oral candidiasis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Pain
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.71%
4/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Peripheral ischaemia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Pneumonia
|
5.9%
33/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.9%
16/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
9/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.5%
14/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Right ventricular failure
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Staphylococcal infection
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Vascular disorders
Vascular occlusion
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Acute psychosis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Asthenia
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cerebral infarction
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Cholangitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Influenza like illness
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Myxoedema
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Pneumonia bacterial
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Presyncope
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Renal and urinary disorders
Renal failure
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Sepsis
|
1.2%
7/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Viral infection
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Clostridium difficile infection
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.4%
25/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.7%
15/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
General physical health deterioration
|
2.3%
13/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Endocrine disorders
Hypopituitarism
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Oedema peripheral
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
6/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.2%
7/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Partial seizures
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Pericardial effusion
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Pyrexia
|
1.2%
7/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Urinary tract infection
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Ear and labyrinth disorders
Vertigo
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
13/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.1%
23/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Blood sodium decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.89%
5/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Bronchitis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Confusional state
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.71%
4/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Device related infection
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Dizziness
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Immune system disorders
Drug hypersensitivity
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Gastroenteritis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Eye disorders
Glaucoma
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Immune system disorders
Hypersensitivity
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Lobar pneumonia
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Malaise
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Mental status changes
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.36%
2/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.53%
3/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
15/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
3.6%
20/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Non-cardiac chest pain
|
0.36%
2/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Platelet count decreased
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
6/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.53%
3/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Syncope
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
4/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
1.4%
8/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.18%
1/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Infections and infestations
H1n1 influenza
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Iiird nerve disorder
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Viith nerve paralysis
|
0.18%
1/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
0.00%
0/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
Other adverse events
| Measure |
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE
n=562 participants at risk
|
PLACEBO + PLATINUM/ETOPOSIDE
n=561 participants at risk
|
|---|---|---|
|
General disorders
Chest pain
|
6.8%
38/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
8.0%
45/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Neutrophil count decreased
|
15.5%
87/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
11.9%
67/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Weight decreased
|
8.2%
46/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
7.3%
41/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
43/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
8.4%
47/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
94/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
14.4%
81/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.1%
169/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
24.6%
138/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Diarrhoea
|
28.3%
159/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
20.7%
116/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Fatigue
|
32.0%
180/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
30.3%
170/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.4%
53/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
8.9%
50/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.5%
121/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
5.0%
28/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
30/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.3%
24/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Haemoglobin decreased
|
6.8%
38/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
5.7%
32/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.4%
47/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
5.5%
31/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Psychiatric disorders
Insomnia
|
9.4%
53/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
11.1%
62/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
115/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
17.3%
97/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Alanine aminotransferase increased
|
8.4%
47/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.6%
26/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Aspartate aminotransferase increased
|
7.8%
44/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.1%
23/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.0%
73/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
15.5%
87/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Nausea
|
41.3%
232/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
37.3%
209/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.4%
199/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
37.1%
208/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
37/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.6%
26/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
75/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
14.8%
83/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Headache
|
11.9%
67/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
10.0%
56/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Asthenia
|
9.8%
55/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
10.9%
61/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
24/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
6.4%
36/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Constipation
|
21.5%
121/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
17.6%
99/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Oedema peripheral
|
6.8%
38/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
4.8%
27/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
General disorders
Pyrexia
|
14.1%
79/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
10.7%
60/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
34/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
5.9%
33/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Anaemia
|
30.4%
171/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
33.7%
189/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Nervous system disorders
Dizziness
|
9.3%
52/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
10.5%
59/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.6%
26/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
5.7%
32/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.6%
234/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
46.5%
261/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
Platelet count decreased
|
6.9%
39/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
8.6%
48/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.6%
82/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
2.7%
15/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
64/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
15.0%
84/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
|
Investigations
White blood cell count decreased
|
9.1%
51/562 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
9.1%
51/561 • From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
|
Additional Information
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