Trial Outcomes & Findings for BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse (NCT NCT01690624)
NCT ID: NCT01690624
Last Updated: 2025-01-27
Results Overview
This trial was discontinued prior to reaching the primary endpoint of determining MTD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days.
Results posted on
2025-01-27
Participant Flow
Phase1, open-label, non-randomized, dose-escalation, 3+3 design study followed by expansion cohort with two separate patient populations:1) patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) who have failed at least one prior line of therapy(2) patients with AML who are in complete remission (CR) with high risk to relapse.
This study initially enrolled patients diagnosed with refractory or relapsed AML who had failed at least 1 prior line of therapy and was later amended to include patients with AML who were in CR with a high risk to relapse.
Participant milestones
| Measure |
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
Patients with relapsed\\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
7
|
3
|
Reasons for withdrawal
| Measure |
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
Patients with relapsed\\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Overall Study
PD based on IWG criteria or clinical PD
|
8
|
5
|
2
|
0
|
|
Overall Study
Adverse event (other than DLT)
|
3
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor is ending trial
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
3
|
0
|
Baseline Characteristics
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse
Baseline characteristics by cohort
| Measure |
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
n=12 Participants
Patients with relapsed\\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
n=8 Participants
Patients with relapsed\\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
60.8 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
72.3 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 17.5 • n=4 Participants
|
62.4 Years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days.Population: MTD evaluable set (non-replaced patients) defined as patients who completed the first two treatment cycles.
This trial was discontinued prior to reaching the primary endpoint of determining MTD.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=27 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Determination of the Maximum Tolerated Dose (MTD) of BI 836858
|
NA Milligram (mg)
No dose limiting toxicity (DLT) events were observed in the highest dose levels studied, therefore, MTD could not be determined
|
NA Milligram (mg)
No DLT events were observed in the highest dose levels studied, therefore, MTD could not be determined
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first administration of BI 836858 to start of the fifth administration, excluding the day of fifth administration, up to 28 days.Population: MTD evaluable set (non-replaced patients) defined as patients who completed the first two treatment cycles.
Dose limiting toxicity was defined as any non-disease-related, non-hematological Adverse Events (AE) of Common Terminology Criteria for AE (CTCAE) grade 3 or higher. Number of patients with DLT during the MTD evaluation period for evaluation for patients with refractory or relapsed acute myeloid leukemia, the first 2 cycles (i.e. patient received at least 4 administrations of BI 836858 and reached end of Cycle 2) and for AML patients in CR with high risk to relapse, the first 2 cycles (i.e. patient has received at least 2 administrations of BI 836858 and reached end of Cycle 2).
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first administration of study drug until the earliest of progressive disease (PD), death or last adequate disease assessment before new anti-cancer therapy, up to 299 days.Population: Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint.
BOR for patients with refractory/relapsed acute myeloid leukemia defined as: -CR:Morphologically leukemia free state/absolute neutrophil count≥1000/microliter(μL)and platelets≥100,000/μL. No transfusion for 1week prior to assessment -CRi:Met criteria for CR, except absolute neutrophils\<1000/μl/platelets\<100,000/μl -PR:Met criteria for CR, except leukemic blasts in bone marrow may range from 5 to 25% as long as count has decreased by at least 50% from pre-study treatment, or\<5% blasts in presence of Auer rods or abnormal morphology -TF:Patient survives≥7 days following completion of initial 2 treatment cycles with persistent leukemia in the last peripheral blood smear or bone marrow or with persistent extramedullary disease - PD:Patient survives\>7 days following completion of initial 2 treatment cycles with increase of blast population in bone marrow or peripheral blood by\>50% or aggravation or new development of extramedullary disease or further deterioration or death due to leukemia
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
CRi
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
TF
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
PD
|
8 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
Not evaluable
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Best Overall Response According to International Working Group (IWG) Criteria Categorized as CompleteRemission(CR), CR With Incomplete Blood Recovery (CRi), PartialRemission (PR), TreatmentFailure (TF) and ProgressiveDisease (PD)
No assessment post-baseline
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first administration of study drug until progressed according to disease assessment, relapse, or death without progression, up to 167 days.Population: Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint.
Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Progression Free Survival for Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
27.5 Days
Interval 17.0 to 64.0
|
29.5 Days
Interval 8.0 to 59.0
|
50.0 Days
Interval 25.0 to
NA = This was not estimable due to insufficient number of patients with event
|
—
|
SECONDARY outcome
Timeframe: From first administration of study drug until progressive disease, relapse, death or start of next anti-AML therapy, up to 167 days.Population: Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only patients with relapsed/refractory AML were planned to be analysed for this endpoint.
Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Time to Treatment Failure for Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
27.5 Days
Interval 17.0 to 32.0
|
29.5 Days
Interval 8.0 to 59.0
|
40.5 Days
Interval 25.0 to 64.0
|
—
|
SECONDARY outcome
Timeframe: From first treatment with study drug until disease progression, relapse or death for AML patients in CR with high risk to relapse, up to 409 days.Population: Treated Set (TS): TS included patients treated with at least 1 dose of BI 836858. Only AML patients in CR were included in the analysis.
Progression-free survival was defined as the time from first treatment with BI 836858 until disease progression, relapse or death for AML patients in CR with high risk to relapse.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=3 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Progression Free Survival for AML Patients in CR With High Risk to Relapse
|
NA Days
NA = This was not estimable due to insufficient number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first treatment with study drug until disease progression, relapse, death or start of next AML therapy for AML patients in CR with high risk to relapse, up to 409 days.Population: TS. Only patients in CR were included in the analysis.
Time to treatment was defined as the time from first treatment with BI 836858 until disease progression, relapse or death or start of next AML therapy.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=3 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Time to Treatment Failure for AML Patients in CR With High Risk to Relapse
|
NA Days
NA = This was not estimable due to insufficient number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Maximum measured plasma concentration (Cmax) after the first infusion is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=6 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Maximum Measured Plasma Concentration (Cmax)
|
873 nanograms per millilitre (ng/ml)
Geometric Coefficient of Variation 207
|
3270 nanograms per millilitre (ng/ml)
Geometric Coefficient of Variation 35.4
|
6100 nanograms per millilitre (ng/ml)
Geometric Coefficient of Variation 82.1
|
9640 nanograms per millilitre (ng/ml)
Geometric Coefficient of Variation 55.7
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Time from dosing to the maximum plasma concentration (tmax) after the first infusion is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=6 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Time From Dosing to the Maximum Plasma Concentration (Tmax)
|
4.43 hours (hrs)
Interval 3.0 to 7.0
|
6.07 hours (hrs)
Interval 5.0 to 8.8
|
5.87 hours (hrs)
Interval 5.0 to 8.45
|
5.92 hours (hrs)
Interval 5.18 to 6.17
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Area under the plasma concentration-time curve over the time interval of one week (AUC0-168) after the first infusion is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=6 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval of One Week (AUC0-168)
|
NA nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation NA
NA=Values below level of detection
|
NA nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation NA
NA=Values below level of detection
|
NA nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation NA
NA=Values below level of detection
|
783000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 37.3
|
SECONDARY outcome
Timeframe: At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Area under the plasma concentration-time curve over the time interval of one treatment cycle (AUC0-tz) is presented. One treatment cycle included a first and a second infusion.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval of One Treatment Cycle (AUC0-tz)
first infusion
|
7730 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 631
|
68100 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 89.4
|
190000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 194
|
807000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 38.1
|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval of One Treatment Cycle (AUC0-tz)
second infusion
|
7980 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 417
|
28100 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 133
|
361000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 32.8
|
—
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC0-infinity) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-infinity)
|
23400 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 137
|
97900 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 114
|
296000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 256
|
1120000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 39.8
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Terminal half-life (t1/2) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2)
|
11.3 hours (hrs)
Geometric Coefficient of Variation 64.3
|
21.4 hours (hrs)
Geometric Coefficient of Variation 91.7
|
34.5 hours (hrs)
Geometric Coefficient of Variation 107
|
94.3 hours (hrs)
Geometric Coefficient of Variation 22.1
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Mean residence time after intravenous infusion (MRT) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Mean Residence Time After Intravenous Infusion (MRT)
|
16.4 hours (hrs)
Geometric Coefficient of Variation 62.1
|
30.8 hours (hrs)
Geometric Coefficient of Variation 85.4
|
50.8 hours (hrs)
Geometric Coefficient of Variation 98.7
|
136 hours (hrs)
Geometric Coefficient of Variation 22.3
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Total plasma clearance (CL) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Total Plasma Clearance (CL)
|
7.11 millilitre/minute (ml/min)
Geometric Coefficient of Variation 137
|
3.40 millilitre/minute (ml/min)
Geometric Coefficient of Variation 114
|
2.25 millilitre/minute (ml/min)
Geometric Coefficient of Variation 256
|
0.595 millilitre/minute (ml/min)
Geometric Coefficient of Variation 39.8
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Apparent volume of distribution during the terminal phase (Vz) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase (Vz)
|
6.99 Litre (l)
Geometric Coefficient of Variation 51.9
|
6.29 Litre (l)
Geometric Coefficient of Variation 30.8
|
6.72 Litre (l)
Geometric Coefficient of Variation 63.9
|
4.85 Litre (l)
Geometric Coefficient of Variation 38.5
|
SECONDARY outcome
Timeframe: At 5 minutes (min) before start of the first BI 836858 infusion at Day 1 and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs and 72 hrs after the first BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Volume of distribution after intravenous infusion at steady state (Vss) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=7 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=5 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Volume of Distribution After Intravenous Infusion at Steady State (Vss)
|
7.01 Litre (l)
Geometric Coefficient of Variation 53.0
|
6.30 Litre (l)
Geometric Coefficient of Variation 29.4
|
6.86 Litre (l)
Geometric Coefficient of Variation 69.5
|
4.85 Litre (l)
Geometric Coefficient of Variation 39.0
|
SECONDARY outcome
Timeframe: At approximately 5 minutes (min) before start of first (Day 1) and second (Day 8) BI 836858 infusion and at 5 hours (hrs), 6 hrs, 9 hrs, 24 hrs, 72 hrs and 168 hrs after first and second BI 836858 infusion.Population: PK parameter analysis set (PKS): This patient set includes all patients in the treated set (TS) who provide at least one pharmacokinetics (PK) parameter.
Area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable data point (AUC0-tz) is presented.
Outcome measures
| Measure |
BI 836858 (Patients With Relapsed\Refractory AML)
n=12 Participants
Comprises all dose cohorts during the dose escalation phase. Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=8 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 Participants
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 Participants
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Data Point (AUC0-tz)
First infusion
|
7730 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 631
|
68100 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 89.4
|
190000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 194
|
807000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 38.1
|
|
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Data Point (AUC0-tz)
Second infusion
|
7980 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 417
|
28100 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 133
|
361000 nanograms*hours/millilitre (ng*h/ml)
Geometric Coefficient of Variation 32.8
|
—
|
Adverse Events
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
Serious events: 9 serious events
Other events: 12 other events
Deaths: 2 deaths
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
Serious events: 8 serious events
Other events: 8 other events
Deaths: 4 deaths
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 2 deaths
BI 836858 40 mg (Patients With AML in CR)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
n=12 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
n=8 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 participants at risk
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Catheter site haemorrhage
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Death
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Fatigue
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Device related infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Liver function test increased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Haemorrhage intracranial
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Delirium
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
Other adverse events
| Measure |
BI836858 10milligram(mg)(Patients With Relapsed\refractoryAML)
n=12 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 10 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 20 mg (Patients With Relapsed\Refractory AML)
n=8 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 20 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With Relapsed\Refractory AML)
n=7 participants at risk
Patients with relapsed\\refractory AML were administered BI 836858 40 mg solution for infusion intravenously on day 1 and day 8 of the 14-day cycles (1 cycle with 2 administrations).
|
BI 836858 40 mg (Patients With AML in CR)
n=3 participants at risk
Patients with AML in complete remission (CR) with high risk to relapse were administered BI 836858 40 mg solution for infusion intravenously on Day 1 of Cycles 1, 2 and 3. From the 4th administration onwards, patients received monthly (every second cycle) infusions (i.e. 4th infusion on Cycle 5 Day 1, 5th infusion on Cycle 7 Day 1, etc.) for overall up to 12 months of treatment unless the patient relapsed or infusions were not tolerated.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
42.9%
3/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
4/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
42.9%
3/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
100.0%
3/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Eye disorders
Cataract
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Eye disorders
Diplopia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Glossodynia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
8/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Asthenia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Chest pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Chills
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Face oedema
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Face pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Fatigue
|
33.3%
4/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Malaise
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Oedema
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Immune system disorders
Graft versus host disease in eye
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Device related infection
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Lip infection
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
41.7%
5/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Laceration
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Blood glucose increased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Platelet count decreased
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
42.9%
3/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Transaminases increased
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
Weight increased
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Investigations
White blood cell count decreased
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
66.7%
2/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
50.0%
4/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Abnormal dreams
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Hallucination
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Illusion
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Mental status changes
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Psychiatric disorders
Sleep disorder
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
3/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
37.5%
3/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
2/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
28.6%
2/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Vascular disorders
Essential hypertension
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
14.3%
1/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
12.5%
1/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
33.3%
1/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
25.0%
2/8 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/7 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
0.00%
0/3 • All AEs, including all-cause mortality, with an onset between start of treatment date and date of last treatment administration + the residual effect period of 30 days, date of death or date of data base lock; up to 409 days.
AEs are presented for trial period.
|
Additional Information
Boehringer Ingelheim, Call Centre
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