Trial Outcomes & Findings for Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML (NCT NCT01957644)
NCT ID: NCT01957644
Last Updated: 2019-02-08
Results Overview
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-02-08
Participant Flow
The trial had 2 parts.
Part 1:Starting dose of volasertib 250 mg administered on Day1 and Day15.The dose was escalated in 50 mg steps up to 300 mg.Flat dosing in Part 1. Part 2:volasertib dosing on Day1 in schedule A, on Day7 in schedule B, on Day1+ Day7 in schedule C.Body surface area (BSA) adapted dosing in Part 2. In each cycle, azacitidine was given from Day1 to 7
Participant milestones
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
1
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
0
|
0
|
1
|
|
Overall Study
Progressive disease / relapse
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Other reason
|
1
|
2
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
Baseline characteristics by cohort
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 Participants
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=6 Participants
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
n=1 Participants
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=2 Participants
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
69.2 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
60.0 years
STANDARD_DEVIATION NA • n=206 Participants
|
64.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
81.0 years
STANDARD_DEVIATION NA • n=31 Participants
|
68.9 years
STANDARD_DEVIATION 8.5 • n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD.
Outcome measures
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 Participants
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=5 Participants
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1
|
NA Milligram (mg)
Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
|
NA Milligram (mg)
Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
|
NA Milligram (mg)
Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
|
NA Milligram (mg)
Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
|
—
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: MTD set
Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented .
Outcome measures
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 Participants
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=5 Participants
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: From randomisation until data cut-off (16Dec2016); up to 159 weeksPopulation: Efficacy set (ES): All the treated patients without any protocol violations related to efficacy
OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria. Complete remission (CR): * Bone marrow: \<5 % myeloblasts with normal maturation of all cell lines\* * Persistent dysplasia will be noted\* * Peripheral blood: * hemoglobin (Hgb) \> 11 Grams Per Decilitre (g/dL) * Platelets \>100 x 109/L * Neutrophils \> 1.0 x 109/L * Blasts 0 % \*Dysplastic changes should consider the normal range of dysplastic changes Partial remission (PR): All CR criteria if abnormal before treatment except: * Bone marrow blasts decreased by \>50% to pre-treatment but still \>5% * Cellularity and morphology not relevant
Outcome measures
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 Participants
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=5 Participants
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=2 Participants
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 Participants
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Percentage of Patients With Objective Response (OR)
|
33.3 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 participants at risk
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=6 participants at risk
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
n=1 participants at risk
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=2 participants at risk
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 participants at risk
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Chest pain
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
General physical health deterioration
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Systemic inflammatory response syndrome
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Anal abscess
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Urosepsis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
Other adverse events
| Measure |
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
n=6 participants at risk
Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
|
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
n=6 participants at risk
Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
n=1 participants at risk
Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
|
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=2 participants at risk
Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
n=1 participants at risk
Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Blood and lymphatic system disorders
Cyclic neutropenia
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
4/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
83.3%
5/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Endocrine disorders
Thyroid mass
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Eye disorders
Eye haemorrhage
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
2/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Asthenia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Chest pain
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Chills
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Fatigue
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Feeling cold
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Inflammation
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Injection site pain
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Oedema
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Hepatobiliary disorders
Hepatic lesion
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Fungal skin infection
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Haematoma infection
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Infected bite
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Infection
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Oral herpes
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Blood creatine increased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Blood folate decreased
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
C-reactive protein increased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Investigations
Weight decreased
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Psychiatric disorders
Libido disorder
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Renal and urinary disorders
Renal disorder
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
3/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
33.3%
2/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
4/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
100.0%
1/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Vascular disorders
Arteriosclerosis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Vascular disorders
Haematoma
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
|
Vascular disorders
Thrombophlebitis
|
16.7%
1/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/6 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
50.0%
1/2 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
0.00%
0/1 • From randomisation until data cut-off (16Dec2016); up to 159 weeks
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER